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CompletedNCT01216683Updated Jun 29, 2023Results posted

Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma

A Phase 2 interventional study of rituximab and Bendamustin in Lymphoma, sponsored by ECOG-ACRIN Cancer Research Group. Completed at 227 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-29.

Sponsored by ECOG-ACRIN Cancer Research Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
289
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab together alone is more effective than giving bendamustine hydrochloride and rituximab together with bortezomib or lenalidomide in treating follicular lymphoma.

PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • To compare the complete remission rate in patients with high-risk follicular lymphoma receiving induction therapy comprising bendamustine hydrochloride and rituximab with vs without bortezomib.
  • To compare the 1-year post-induction disease-free survival rate in patients receiving continuation therapy comprising rituximab with vs without lenalidomide.

Secondary

  • To determine the 3-year progression-free survival and the 5-year overall survival of these patients.
  • To evaluate patient-reported outcomes at baseline and during treatment to determine differences in symptom palliation, treatment-related symptoms, and overall health-related quality of life.
  • To examine the association between baseline Follicular Lymphoma International Prognostic Index (FLIPI) information and outcome of these patients.
  • To examine the association between baseline and end-of-treatment patient comorbidities assessed by the Cumulative Illness Rating Scale (CIRS) and outcome.
  • To create an image and tissue bank including serial PET/CT scans, diagnostic paraffin-embedded tissue, germline DNA, and serial blood and bone marrow samples sufficient to support proposed and future studies of tumor and host characteristics that may predict for clinical outcome, including treatment arm effects, and enhance existing prognostic indices. (exploratory)
  • To evaluate the rate of peripheral neuropathy associated with subcutaneous and intravenous bortezomib.

OUTLINE: Patients are stratified according to FLIPI-1score (0-2 vs 3 vs 4-5) and Groupe d'Etude des Lymphomes Folliculaires (GELF) tumor burden (low vs high). Patients are randomized to 1 of 3 treatment arms.

  • Arm A then Arm D

    • Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    • Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

  • Arm B then Arm E

    • Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    • Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.

  • Arm C then Arm F

    • Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    • Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life (including fatigue, neurotoxicity, anxiety, and depression) is assessed by questionnaire at baseline and periodically during study therapy.

Blood, bone marrow, and tissue samples may be collected periodically for correlative studies and for a repository.

After completion of study therapy, patients are followed up periodically for 15 years.

02

Conditions studied

  • Lymphoma

Keywords

  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 289 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

ECOG-ACRIN Cancer Research Group is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria (Induction):

  • Histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin lymphoma with no evidence of transformation to large cell histology

    • Patients having both diffuse and follicular architectural elements are eligible if the histology is predominantly follicular (i.e., ≥ 50% of the cross-sectional area) and there is no evidence of transformation to a large cell histology

    • Diagnostic confirmation (i.e., core needle or excisional lymph node biopsy) required if the interval since tissue diagnosis of low-grade malignant lymphoma is > 24 months

      • Bone marrow biopsy alone not acceptable
  • Stage II, III, or IV AND grade 1, 2, or 3a disease

  • Must meet criteria for High Tumor Burden (higher risk) as defined by either the Groupe D'Etude des Lymphomes Follicularies (GELF) criteria OR the follicular lymphoma international prognostic index (FLIPI) as defined below:

    • Patient must meet ≥ 1 of the following GELF criteria:

      • Nodal or extranodal mass ≥ 7 cm
      • At least 3 nodal masses > 3.0 cm in diameter
      • Systemic symptoms due to lymphoma or B symptoms
      • Splenomegaly with spleen > 16 cm by CT scan
      • Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal) or pleural or peritoneal serous effusion due to lymphoma (irrespective of cell content)
      • Leukemic presentation (≥ 5.0 x 10\^9/L malignant circulating follicular cells)
      • Cytopenias (polymorphonuclear leukocytes \< 1.0 X 10\^9/L, hemoglobin \< 10 g/dL, and/or platelets \< 100 x 10\^9/L)

    • Patient must have a FLIPI-1 score of 3, 4, or 5 (1 point per criterion below):

      • Age ≥ 60 years
      • Stage III-IV disease
      • Hemoglobin level \< 12 g/dL
      • > 4 nodal areas
      • Serum lactate dehydrogenase (LDH) level above normal

  • At least 1 objective measurable disease parameter

    • Baseline measurements and evaluations (PET and CT) obtained within 6 weeks of randomization
    • Measurable disease in the liver is required if the liver is the only site of lymphoma

  • HIV-positive patients must meet all of the following criteria:

    • HIV is sensitive to antiretroviral therapy
    • Must be willing to take effective antiretroviral therapy if indicated
    • No history of CD4 \< 300 cells/mm³ prior to or at the time of lymphoma diagnosis
    • No history of AIDS-defining conditions
    • If on antiretroviral therapy, must not be taking zidovudine or stavudine
    • Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP) during therapy and ≥ 2 months following completion of study therapy or until the CD4 cells recover to over 250 cells/mm³
  • ECOG performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³ (includes neutrophils and bands)
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 2.0 mg/dL
  • Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 5 x upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 x ULN
  • Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert disease should contact the study PI)
  • Negative pregnancy test
  • Fertile patients must use 2 effective methods (1 highly effective and 1 additional effective method) of contraception ≥ 28 days before, during, and for ≥ 28 days after completing study treatment
  • Must register into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist® (for patients randomized to arm C and proceed onto arm F)

Exclusion Criteria (Induction):

  • Prior chemotherapy, radiotherapy, or immunotherapy for lymphoma

    • Prednisone or other corticosteroids used for non-lymphomatous conditions will not be considered as prior chemotherapy
    • A prior/recent short course (\< 2 weeks) of steroids for symptom relief of lymphoma-related symptoms is allowed
  • Recent history of malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ≥ 2 years
  • Pregnant or nursing
  • Active, uncontrolled infections (afebrile for > 48 hours off antibiotics)
  • ≥ grade 2 neuropathy
  • Myocardial infarction within the past 6 months
  • NYHA class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Known hypersensitivity to boron or mannitol
  • Chronic carriers of hepatitis B virus (HBV) with positive hepatitis surface antigen (HBsAg +)

Inclusion Criteria (Continuation):

  • Patient must have improved their response or have had no interval change in their tumor measurements with restaging from Induction cycle 3 to 6 as determined at Cycle 6 restaging.
  • Adequate organ function
  • ECOG performance status 0-2
  • Patients with a prior history of HBV infection, but immune, with only IgG hepatitis core antibody positive (HBcAb+), must receive antiviral prophylaxis (e.g., lamivudine 100 mg po daily) for ≥ 1 week prior to course 1 and throughout induction and continuation therapy and for ≥ 12 months after the last rituximab dose

  • Additional requirements for Arm C induction patients registering to arm F:

    • Patients must be willing to take deep vein thrombosis (DVT) prophylaxis. Subjects with a history of a thrombotic vascular event will be required to have full anticoagulation, therapeutic doses of low molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0, or any other accepted full anticoagulation regimen (e.g. direct thrombin inhibitors or Factor Xa inhibitors) with appropriate monitoring for that agent. Subjects without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis. Subjects who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen.
    • Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study/lenalidomide: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation/stopping lenalidomide. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
    • Patient must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment.
    • All males, regardless of whether they have undergone a successful vasectomy, must agree to use a latex condom during sexual contact with a female of childbearing potential, or to practice complete abstinence from heterosexual intercourse with any female of childbearing potential during the cycles of continuation therapy of which lenalidomide are taken and for at least 28 days after discontinuation/stopping lenalidomide. Patient must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment.
    • Must register into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®

Exclusion Criteria (Continuation):

  • Active, uncontrolled infections (afebrile for > 48 hours off antibiotics)
  • ≥ grade 2 neuropathy

  • Additional requirements for Arm C induction patients registering to arm F:

    • Not pregnant or breast-feeding
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
289 participants (actual)

Study arms

  • Experimental
    Arm A then Arm D (Induction with Bendamustine + Rituximab; Continuation with Rituximab)

    Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

    Biological: rituximab · Drug: Bendamustin

  • Experimental
    Arm B then Arm E (Induction with Bendamustine + Rituximab + Bortezomib; Continuation with Rituximab)

    Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.

    Biological: rituximab · Drug: Bendamustin · Drug: bortezomib

  • Experimental
    Arm C then Arm F (Induction with Bendamustine+Rituximab; Continuation with Lenalidomide + Rituximab)

    Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

    Biological: rituximab · Drug: Bendamustin · Drug: lenalidomide

Interventions

  • Biologicalrituximab

    Given IV

    Also known as: IDEC-C2B8, Chimeric anti-CD20 monoclonal antibody, Rituxan

  • DrugBendamustin

    Given IV

    Also known as: Bendamustine hydrochloride, CEP-18083, TREANDA

  • Drugbortezomib

    Given IV

    Also known as: MLN341, LDP-341, Velcade®, PS-341

  • Druglenalidomide

    Given orally

    Also known as: IMiD compound CC-5013, Revlimid®

06

What researchers measure

Primary outcomes

  1. Complete Remission (CR) Rate

    Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. This analysis was conducted among 222 evaluable patients for the primary analysis. The purpose of this analysis is to compare the complete remission rate of rituximab + bendamustine vs. bortezomib + rituximab + bendamustine as induction therapy, therefore, the proportion of patients with complete remission was compared between Arm B (bortezomib + rituximab + bendamustine) and Arms A and C combined (rituximab + bendamustine).

    Time frame: Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years

  2. 1-year Post-induction Disease-free Survival (DFS) Rate

    1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion. The purpose of this analysis is to compare the 1-year post-induction disease-free survival (DFS) rate with rituximab plus lenalidomide to rituximab alone as continuation therapy following induction treatment of bendamustine+rituximab, therefore, patients with induction treatment of bendamustine + rituximab + bortezomib were not included in this analysis.

    Time frame: Assessed at 1 year post-induction, approximately 1.5 years

Secondary outcomes

  1. 3-year Progression-free Survival Rate

    Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. 3-year progression-free survival rate is the proportion of patients who were progression-free and alive at 3 years estimated using the method of Kaplan-Meier. Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, \>=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.

    Time frame: Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry

  2. 5-year Overall Survival Rate

    Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier.

    Time frame: Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry

  3. Complete Remission (CR) Rate

    Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. This analysis was conducted among 222 evaluable patients. The proportion of patients with complete remission was compared between patients with Follicular Lymphoma International Prognostic Index (FLIPI) of 3-5 and patients with FLIPI of 0-2/unknown. The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age \> 60 years, Ann Arbor stage III-IV, hemoglobin level \< 12 gm/dL, \>4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.

    Time frame: Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years

  4. 1-year Disease-free Survival (DFS) Rate

    1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion. This analysis was conducted among 203 evaluable patients in the continuation treatment portion of the study. The 1-year post induction disease-free survival rate was compared between patients with FLIPI of 3-5 and patients with FLIPI of 0-2/unknown. The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age \> 60 years, Ann Arbor stage III-IV, hemoglobin level \< 12 gm/dL, \>4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.

    Time frame: Assessed at 1 year post-induction, approximately 1.5 years

  5. Progression-free Survival

    Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, \>=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. The five FLIPI risk factors were: age \> 60 years, Ann Arbor stage III-IV, hemoglobin level \< 12 gm/dL, \>4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.

    Time frame: Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry

  6. 5-year Overall Survival Rate

    Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier. The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age \> 60 years, Ann Arbor stage III-IV, hemoglobin level \< 12 gm/dL, \>4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.

    Time frame: Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry

  7. Complete Remission (CR) Rate

    Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. This analysis was conducted among 250 evaluable patients with Cumulative Illness Rating Scale (CIRS) data available. The proportion of patients with complete remission was compared between patients with CIRS \<10 and patients with CIRS \>=10. Higher CIRS scores indicate higher severity with max score of 56 points.

    Time frame: Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years

  8. 1-year Disease-free Survival (DFS) Rate

    1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion. This analysis was conducted among 250 evaluable patients with Cumulative Illness Rating Scale (CIRS) data available. The proportion of patients disease-free and alive at 1 year post induction treatment was compared between patients with CIRS \<10 and patients with CIRS \>=10. Higher CIRS scores indicate higher severity with max score of 56 points.

    Time frame: Assessed at 1 year post-induction, approximately 1.5 years

  9. 3-year Progression-free Survival Rate

    Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. 3-year progression-free survival rate is the proportion of patients who were progression-free and alive at 3 years estimated using the method of Kaplan-Meier. Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, \>=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. The 3-year progression-free survival rate is reported by Cumulative Illness Rating Scale (CIRS) score (\<10 vs. \>=10). Higher CIRS scores indicate higher severity with max score of 56 points.

    Time frame: Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry

  10. 5-year Overall Survival Rate

    Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier. The 5-year overall survival rate is reported by Cumulative Illness Rating Scale (CIRS) score (\<10 vs. \>=10). Higher CIRS scores indicate higher severity with max score of 56 points.

    Time frame: Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry

  11. Proportion of Patients With Grade 3 or Higher Peripheral Neuropathy

    Peripheral neuropathy was assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Proportion of patients with grade 3 or higher peripheral neuropathy was compared between patients with subcutaneous bortezomib and patients with intravenous bortezomib.

    Time frame: Assessed every cycle during treatment and for 30 days after discontinuation of treatment, up to 15 years

  12. Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Baseline

    The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.

    Time frame: Assessed at baseline

  13. Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Mid-treatment

    The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life. FACT-G total score at cycle 3 is considered as mid-treatment score. If FACT-G total score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.

    Time frame: Assessed at cycle 3 or cycle 4, approximately 3 or 4 months

  14. Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at End of Induction Treatment

    The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.

    Time frame: Assessed at cycle 6, approximately 6 months

  15. Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Baseline

    The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.

    Time frame: Assessed at baseline

  16. Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Mid-induction Treatment

    The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life. FACT-Lym subscale score at cycle 3 is considered as mid-treatment score. If FACT-Lym subscale score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.

    Time frame: Assessed at cycle 3 or cycle 4, approximately 3 or 4 months

  17. Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at End of Induction Treatment

    The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.

    Time frame: Assessed at cycle 6, approximately 6 months

  18. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Baseline

    The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.

    Time frame: Assessed at baseline

  19. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Mid-induction Treatment

    The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life. FACIT-Fatigue subscale score at cycle 3 is considered as mid-treatment score. If FACIT-Fatigue subscale score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.

    Time frame: Assessed at cycle 3 or cycle 4, approximately 3 or 4 months

  20. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at End of Induction Treatment

    The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.

    Time frame: Assessed at cycle 6, approximately 6 months

  21. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Baseline

    The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.

    Time frame: Assessed at baseline

  22. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Mid-induction Treatment

    The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.

    Time frame: Assessed at cycle 3, approximately 3 months

  23. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at the End of Induction Treatment

    The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.

    Time frame: Assessed at end of induction treatment (cycle 6), approximately 6 months

07

Results

Posted Feb 23, 2021

Participant flow

This study was activated on December 13, 2010, accrued its first patient on February 9, 2011, and closed on May 13, 2015, with final accrual of 289 patients

Induction
Participant flow — Induction
MilestoneArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Started6599125
Received treatment and assessed for toxicities6593122
Eligible and treated5985114
Included in the primary analysis of complete remission rate during induction treatment488589
Completed6180104
Not completed41921
Withdrew: Never started treatment063
Withdrew: Lack of efficacy437
Withdrew: Adverse event055
Withdrew: Death002
Withdrew: Withdrawal by subject042
Withdrew: Other disease012
Continuation
Participant flow — Continuation
MilestoneArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Started597194
Received continuation treatment597089
Completed445651
Not completed151543
Withdrew: Lack of efficacy327
Withdrew: Adverse event5316
Withdrew: Death102
Withdrew: Withdrawal by subject459
Withdrew: Other diseases021
Withdrew: Physician decision101
Withdrew: Non-compliance101
Withdrew: Insurance change010
Withdrew: Mistakenly stayed on treatment for longer than expected010
Withdrew: Not reported001
Withdrew: Never started treatment015

Outcome measures

PrimaryComplete Remission (CR) Rate

Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. This analysis was conducted among 222 evaluable patients for the primary analysis. The purpose of this analysis is to compare the complete remission rate of rituximab + bendamustine vs. bortezomib + rituximab + bendamustine as induction therapy, therefore, the proportion of patients with complete remission was compared between Arm B (bortezomib + rituximab + bendamustine) and Arms A and C combined (rituximab + bendamustine).

Time frame:
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
Reported as:
Number · proportion of participants
Complete Remission (CR) Rate
proportion of participantsArm A and Arm C (Induction With Bendamustine + Rituximab)Arm B (Induction With Bendamustine + Rituximab + Bortezomib)
Complete Remission (CR) Rate0.62 (0.53 to 0.70)0.75 (0.65 to 0.84)
Statistical analysis
  • Arm A and Arm C (Induction With Bendamustine + Rituximab) vs Arm B (Induction With Bendamustine + Rituximab + Bortezomib) · Cochran-Mantel-Haenszel · p = 0.02 (one-sided p-value)
Primary1-year Post-induction Disease-free Survival (DFS) Rate

1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion. The purpose of this analysis is to compare the 1-year post-induction disease-free survival (DFS) rate with rituximab plus lenalidomide to rituximab alone as continuation therapy following induction treatment of bendamustine+rituximab, therefore, patients with induction treatment of bendamustine + rituximab + bortezomib were not included in this analysis.

Time frame:
Assessed at 1 year post-induction, approximately 1.5 years
Reported as:
Number · proportion of participants
1-year Post-induction Disease-free Survival (DFS) Rate
proportion of participantsArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
1-year Post-induction Disease-free Survival (DFS) Rate0.85 (0.72 to 0.93)0.67 (0.56 to 0.77)
Statistical analysis
  • Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab) vs Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab) · Cochran-Mantel-Haenszel · p = 0.02Cochran-Mantel-Haenszel test stratified on Groupe d'Etude des Lymphomes Folliculaires status and Follicular Lymphoma International Prognostic Index
Secondary3-year Progression-free Survival Rate

Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. 3-year progression-free survival rate is the proportion of patients who were progression-free and alive at 3 years estimated using the method of Kaplan-Meier. Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, \>=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.

Time frame:
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Reported as:
Number · proportion of participants
3-year Progression-free Survival Rate
proportion of participantsArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
3-year Progression-free Survival Rate0.77 (0.65 to 0.90)0.82 (0.74 to 0.91)0.76 (0.67 to 0.85)
Secondary5-year Overall Survival Rate

Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier.

Time frame:
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Reported as:
Number · proportion of participants
5-year Overall Survival Rate
proportion of participantsArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
5-year Overall Survival Rate0.87 (0.79 to 0.97)0.86 (0.77 to 0.94)0.83 (0.75 to 0.91)
SecondaryComplete Remission (CR) Rate

Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. This analysis was conducted among 222 evaluable patients. The proportion of patients with complete remission was compared between patients with Follicular Lymphoma International Prognostic Index (FLIPI) of 3-5 and patients with FLIPI of 0-2/unknown. The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age \> 60 years, Ann Arbor stage III-IV, hemoglobin level \< 12 gm/dL, \>4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.

Time frame:
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
Reported as:
Number · proportion of participants
Complete Remission (CR) Rate
proportion of participantsFLIPI 0-2/UnknownFLIPI 3-5
Complete Remission (CR) Rate0.71 (0.61 to 0.80)0.64 (0.54 to 0.72)
Secondary1-year Disease-free Survival (DFS) Rate

1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion. This analysis was conducted among 203 evaluable patients in the continuation treatment portion of the study. The 1-year post induction disease-free survival rate was compared between patients with FLIPI of 3-5 and patients with FLIPI of 0-2/unknown. The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age \> 60 years, Ann Arbor stage III-IV, hemoglobin level \< 12 gm/dL, \>4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.

Time frame:
Assessed at 1 year post-induction, approximately 1.5 years
Reported as:
Number · proportion of participants
1-year Disease-free Survival (DFS) Rate
proportion of participantsFLIPI 0-2/UnknownFLIPI 3-5
1-year Disease-free Survival (DFS) Rate0.84 (0.74 to 0.90)0.74 (0.65 to 0.82)
SecondaryProgression-free Survival

Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, \>=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. The five FLIPI risk factors were: age \> 60 years, Ann Arbor stage III-IV, hemoglobin level \< 12 gm/dL, \>4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.

Time frame:
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Reported as:
Median · years
Progression-free Survival
yearsFLIPI 0-2/UnknownFLIPI 3-5
Progression-free Survival6.1 (6.1 to NA)6.2 (4.5 to NA)
Secondary5-year Overall Survival Rate

Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier. The FLIPI was developed in order to predict prognosis of patients with newly diagnosed follicular lymphoma (FL). The five FLIPI risk factors were: age \> 60 years, Ann Arbor stage III-IV, hemoglobin level \< 12 gm/dL, \>4 nodal areas, and serum LDH level above normal. The FLIPI score was calculated by summing the number of risk factors. The higher the FLIPI score, the worse the prognosis.

Time frame:
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Reported as:
Number · proportion of participants
5-year Overall Survival Rate
proportion of participantsFLIPI 0-2/UnknownFLIPI 3-5
5-year Overall Survival Rate0.90 (0.84 to 0.96)0.81 (0.74 to 0.89)
SecondaryComplete Remission (CR) Rate

Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. This analysis was conducted among 250 evaluable patients with Cumulative Illness Rating Scale (CIRS) data available. The proportion of patients with complete remission was compared between patients with CIRS \<10 and patients with CIRS \>=10. Higher CIRS scores indicate higher severity with max score of 56 points.

Time frame:
Assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years
Reported as:
Number · proportion of participants
Complete Remission (CR) Rate
proportion of participantsCIRS <10CIRS >=10
Complete Remission (CR) Rate0.70 (0.63 to 0.76)0.70 (0.54 to 0.83)
Secondary1-year Disease-free Survival (DFS) Rate

1-year post induction disease-free survival rate is defined as the proportion of patients achieving complete remission during induction treatment and are alive and maintaining complete remission at 1 year after induction completion. This analysis was conducted among 250 evaluable patients with Cumulative Illness Rating Scale (CIRS) data available. The proportion of patients disease-free and alive at 1 year post induction treatment was compared between patients with CIRS \<10 and patients with CIRS \>=10. Higher CIRS scores indicate higher severity with max score of 56 points.

Time frame:
Assessed at 1 year post-induction, approximately 1.5 years
Reported as:
Number · proportion of participants
1-year Disease-free Survival (DFS) Rate
proportion of participantsCIRS <10CIRS >=10
1-year Disease-free Survival (DFS) Rate0.62 (0.55 to 0.69)0.65 (0.49 to 0.79)
Secondary3-year Progression-free Survival Rate

Progression-free survival is defined as the time from registration of induction treatment to progression, relapse or death, whichever occurs first. Patients alive without documented progression are censored at last disease assessment. 3-year progression-free survival rate is the proportion of patients who were progression-free and alive at 3 years estimated using the method of Kaplan-Meier. Progression/relapse is defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, \>=50% increase from nadir in the SPD of any previously involved nodes or extranodal masses or the size of other lesions, or \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. The 3-year progression-free survival rate is reported by Cumulative Illness Rating Scale (CIRS) score (\<10 vs. \>=10). Higher CIRS scores indicate higher severity with max score of 56 points.

Time frame:
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Reported as:
Number · proportion of participants
3-year Progression-free Survival Rate
proportion of participantsCIRS <10CIRS >=10
3-year Progression-free Survival Rate0.83 (0.77 to 0.88)0.68 (0.54 to 0.85)
Secondary5-year Overall Survival Rate

Overall survival is defined as the time from randomization to death or date last known alive. 5-year overall survival rate is the proportion of patients who were alive at 5 years estimated using the method of Kaplan-Meier. The 5-year overall survival rate is reported by Cumulative Illness Rating Scale (CIRS) score (\<10 vs. \>=10). Higher CIRS scores indicate higher severity with max score of 56 points.

Time frame:
Assessed every cycle during treatment and every 6 months between 2 and 5 years from study entry
Reported as:
Number · proportion of participants
5-year Overall Survival Rate
proportion of participantsCIRS <10CIRS >=10
5-year Overall Survival Rate0.87 (0.83 to 0.92)0.80 (0.69 to 0.94)
SecondaryProportion of Patients With Grade 3 or Higher Peripheral Neuropathy

Peripheral neuropathy was assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Proportion of patients with grade 3 or higher peripheral neuropathy was compared between patients with subcutaneous bortezomib and patients with intravenous bortezomib.

Time frame:
Assessed every cycle during treatment and for 30 days after discontinuation of treatment, up to 15 years
Reported as:
Number · proportion of participants
Proportion of Patients With Grade 3 or Higher Peripheral Neuropathy
proportion of participantsSubcutaneous BortezomibIntravenous Bortezomib
Proportion of Patients With Grade 3 or Higher Peripheral Neuropathy0.06 (0.002 to 0.29)0.12 (0.06 to 0.21)
SecondaryFunctional Assessment of Cancer Therapy - General (FACT-G) Total Score at Baseline

The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.

Time frame:
Assessed at baseline
Reported as:
Mean · score on a scale
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Baseline
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Baseline83.9 ± 14.284.7 ± 15.586.0 ± 16.0
SecondaryFunctional Assessment of Cancer Therapy - General (FACT-G) Total Score at Mid-treatment

The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life. FACT-G total score at cycle 3 is considered as mid-treatment score. If FACT-G total score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.

Time frame:
Assessed at cycle 3 or cycle 4, approximately 3 or 4 months
Reported as:
Mean · score on a scale
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Mid-treatment
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Mid-treatment85.5 ± 15.784.2 ± 16.485.2 ± 15.9
SecondaryFunctional Assessment of Cancer Therapy - General (FACT-G) Total Score at End of Induction Treatment

The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life.

Time frame:
Assessed at cycle 6, approximately 6 months
Reported as:
Mean · score on a scale
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at End of Induction Treatment
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at End of Induction Treatment86.0 ± 17.786.5 ± 13.984.9 ± 18.2
SecondaryFunctional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Baseline

The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.

Time frame:
Assessed at baseline
Reported as:
Mean · score on a scale
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Baseline
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Baseline43.8 ± 8.744.3 ± 9.344.9 ± 10.6
SecondaryFunctional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Mid-induction Treatment

The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life. FACT-Lym subscale score at cycle 3 is considered as mid-treatment score. If FACT-Lym subscale score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.

Time frame:
Assessed at cycle 3 or cycle 4, approximately 3 or 4 months
Reported as:
Mean · score on a scale
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Mid-induction Treatment
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at Mid-induction Treatment47.9 ± 7.446.8 ± 8.746.5 ± 9.5
SecondaryFunctional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at End of Induction Treatment

The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is a 15-item questionnaire that evaluates disease-related symptoms and concerns specific to lymphoma with a scale of 0-4. The FACT-Lym subscale score ranges between 0 and 60. The higher the score, the better the quality of life.

Time frame:
Assessed at cycle 6, approximately 6 months
Reported as:
Mean · score on a scale
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at End of Induction Treatment
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale Score at End of Induction Treatment48.9 ± 7.548.4 ± 8.547.2 ± 9.9
SecondaryFunctional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Baseline

The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.

Time frame:
Assessed at baseline
Reported as:
Mean · score on a scale
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Baseline
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Baseline38.6 ± 10.537.9 ± 11.438.1 ± 12.1
SecondaryFunctional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Mid-induction Treatment

The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life. FACIT-Fatigue subscale score at cycle 3 is considered as mid-treatment score. If FACIT-Fatigue subscale score at cycle 3 is not available, the score at cycle 4 will be used as the mid-treatment score.

Time frame:
Assessed at cycle 3 or cycle 4, approximately 3 or 4 months
Reported as:
Mean · score on a scale
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Mid-induction Treatment
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at Mid-induction Treatment39.2 ± 9.034.5 ± 10.936.3 ± 12.3
SecondaryFunctional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at End of Induction Treatment

The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is comprised of 13 items that assess fatigue and its impact with a scale of 0-4. The FACIT-Fatigue subscale score ranges between 0 and 52. The higher the score, the better the quality of life.

Time frame:
Assessed at cycle 6, approximately 6 months
Reported as:
Mean · score on a scale
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at End of Induction Treatment
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Subscale Score at End of Induction Treatment39.9 ± 10.139.1 ± 9.836.3 ± 12.2
SecondaryFunctional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Baseline

The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.

Time frame:
Assessed at baseline
Reported as:
Mean · score on a scale
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Baseline
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Baseline39.9 ± 4.338.7 ± 6.038.8 ± 5.5
SecondaryFunctional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Mid-induction Treatment

The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.

Time frame:
Assessed at cycle 3, approximately 3 months
Reported as:
Mean · score on a scale
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Mid-induction Treatment
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at Mid-induction Treatment40.0 ± 4.638.6 ± 5.139.1 ± 5.2
SecondaryFunctional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at the End of Induction Treatment

The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) subscale is comprised of 11 items that assess neurotoxicity with a scale of 0-4. The FACT-GOG-NTX subscale score ranges between 0 and 44. The higher the score, the better the quality of life.

Time frame:
Assessed at end of induction treatment (cycle 6), approximately 6 months
Reported as:
Mean · score on a scale
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at the End of Induction Treatment
score on a scaleArm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) Subscale Score at the End of Induction Treatment39.8 ± 4.036.1 ± 6.539.0 ± 5.9

Adverse events

Collected over Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A2/65 (3.1%)51/65 (78.5%)64/65 (98.5%)
Arm B9/99 (9.1%)78/93 (83.9%)92/93 (98.9%)
Arm C12/125 (9.6%)96/122 (78.7%)122/122 (100%)
Arm D6/59 (10.2%)39/59 (66.1%)59/59 (100%)
Arm E7/71 (9.9%)44/70 (62.9%)70/70 (100%)
Arm F10/94 (10.6%)77/89 (86.5%)88/89 (98.9%)
Most frequent serious events
Showing 10 of 95
Most frequent serious events
EventArm AArm BArm CArm DArm EArm F
Lymphocyte count decreasedInvestigations44/6561/9377/12233/5935/7056/89
Neutrophil count decreasedInvestigations22/6533/9335/12212/5913/7058/89
White blood cell decreasedInvestigations19/6532/9330/12214/5911/7052/89
Peripheral sensory neuropathyNervous system disorders0/6511/931/1220/593/700/89
Febrile neutropeniaBlood and lymphatic system disorders4/653/936/1221/592/709/89
Platelet count decreasedInvestigations2/659/937/1220/592/702/89
AnemiaBlood and lymphatic system disorders2/653/935/1220/591/707/89
Lung infectionInfections and infestations1/653/930/1221/590/707/89
FatigueGeneral disorders2/656/939/1221/590/705/89
DiarrheaGastrointestinal disorders0/656/932/1221/590/703/89
Most frequent other events
Showing 10 of 69
Most frequent other events
EventArm AArm BArm CArm DArm EArm F
White blood cell decreasedInvestigations42/6560/9378/12239/5945/7078/89
FatigueGeneral disorders53/6574/9392/12238/5951/7067/89
Lymphocyte count decreasedInvestigations35/6555/9362/12239/5954/7065/89
Platelet count decreasedInvestigations26/6565/9365/12218/5921/7048/89
Neutrophil count decreasedInvestigations26/6546/9347/12225/5930/7061/89
Peripheral sensory neuropathyNervous system disorders15/6561/9324/12215/5942/7022/89
AnemiaBlood and lymphatic system disorders39/6559/9367/12232/5935/7054/89
NauseaGastrointestinal disorders37/6556/9374/12210/598/7026/89
ConstipationGastrointestinal disorders22/6545/9346/1227/597/7027/89
DiarrheaGastrointestinal disorders20/6544/9327/12210/5911/7034/89

Baseline characteristics

Eligible and treated patients are included in this analysis.

Age, Continuous
Age, Continuous(years)Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)Total
Median59 (36 to 79)60 (24 to 86)61 (24 to 88)61 (24 to 88)
Sex: Female, Male
Sex: Female, Male(Participants)Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)Total
Female263456116
Male335158142
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)Total
Hispanic or Latino2259
Not Hispanic or Latino5582107244
Unknown or Not Reported2125
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm A Then Arm D (Induction With Bendamustine + Rituximab; Continuation With Rituximab)Arm B Then Arm E (Induction With Bendamustine + Rituximab + Bortezomib; Continuation With Rituximab)Arm C Then Arm F (Induction With Bendamustine+Rituximab; Continuation With Lenalidomide + Rituximab)Total
American Indian or Alaska Native0101
Asian1315
Native Hawaiian or Other Pacific Islander0000
Black or African American41611
White5378102233
More than one race0000
Unknown or Not Reported1258
08

Study locations

227 sites
  • Marin Cancer Care Inc
    Greenbrae, California 94904, United States
  • Salinas Valley Memorial
    Salinas, California 93901, United States
  • Stanford University Hospitals and Clinics
    Stanford, California 94305, United States
  • The Medical Center of Aurora
    Aurora, Colorado 80012, United States
  • Boulder Community Hospital
    Boulder, Colorado 80301, United States
  • Rocky Mountain Cancer Centers-Boulder
    Boulder, Colorado 80304, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • Exempla Saint Joseph Hospital
    Denver, Colorado 80218, United States
  • Presbyterian - Saint Lukes Medical Center - Health One
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers-Midtown
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers-Rose
    Denver, Colorado 80220, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • Colorado Cancer Research Program CCOP
    Denver, Colorado 80224-2522, United States
  • Colorado Blood Cancer Institute
    Denver, Colorado 80907, United States
  • Comprehensive Cancer Care and Research Institute of Colorado LLC
    Englewood, Colorado 80113, United States
  • Swedish Medical Center
    Englewood, Colorado 80113, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • Mountain Blue Cancer Care Center
    Golden, Colorado 80401, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Rocky Mountain Cancer Centers-Greenwood Village
    Greenwood Village, Colorado 80111, United States
  • Rocky Mountain Cancer Centers-Lakewood
    Lakewood, Colorado 80228, United States
  • Saint Anthony Hospital
    Lakewood, Colorado 80228, United States
  • Littleton Adventist Hospital
    Littleton, Colorado 80122, United States
  • Rocky Mountain Cancer Centers-Sky Ridge
    Lone Tree, Colorado 80124, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Longmont United Hospital
    Longmont, Colorado 80501, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • Parker Adventist Hospital
    Parker, Colorado 80138, United States
  • Rocky Mountain Cancer Centers-Parker
    Parker, Colorado 80138, United States
  • Saint Mary Corwin Medical Center
    Pueblo, Colorado 81004, United States
  • North Suburban Medical Center
    Thornton, Colorado 80229, United States
  • Exempla Lutheran Medical Center
    Wheat Ridge, Colorado 80033, United States
  • Christiana Care Health System-Christiana Hospital
    Newark, Delaware 19718, United States
  • Emory University/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • Georgia Regents University Medical Center
    Augusta, Georgia 30912, United States
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
  • Rush - Copley Medical Center
    Aurora, Illinois 60504, United States
  • Illinois CancerCare-Bloomington
    Bloomington, Illinois 61701, United States
  • Saint Joseph Medical Center
    Bloomington, Illinois 61701, United States
  • Graham Hospital Association
    Canton, Illinois 61520, United States
  • Illinois CancerCare-Canton
    Canton, Illinois 61520, United States
  • Illinois CancerCare-Carthage
    Carthage, Illinois 62321, United States
  • Memorial Hospital
    Carthage, Illinois 62321, United States
  • Centralia Oncology Clinic
    Centralia, Illinois 62801, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Carle on Vermilion
    Danville, Illinois 61832, United States
  • Cancer Care Center of Decatur
    Decatur, Illinois 62526, United States
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
  • Carle Physician Group-Effingham
    Effingham, Illinois 62401, United States
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
  • Eureka Hospital
    Eureka, Illinois 61530, United States
  • Illinois CancerCare-Eureka
    Eureka, Illinois 61530, United States
  • Illinois CancerCare Galesburg
    Galesburg, Illinois 61401, United States
  • Mason District Hospital
    Havana, Illinois 62644, United States
  • Hinsdale Hematology Oncology Associates Incorporated
    Hinsdale, Illinois 60521, United States
  • Illinois CancerCare-Kewanee Clinic
    Kewanee, Illinois 61443, United States
  • North Shore Hematology Oncology
    Libertyville, Illinois 60048, United States
  • Illinois CancerCare-Macomb
    Macomb, Illinois 61455, United States
  • Mcdonough District Hospital
    Macomb, Illinois 61455, United States
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois 61938, United States
  • Illinois CancerCare-Monmouth
    Monmouth, Illinois 61462, United States
  • Illinois Cancer Specialists-Niles
    Niles, Illinois 60714, United States
  • Bromenn Regional Medical Center
    Normal, Illinois 61761, United States
  • Community Cancer Center Foundation
    Normal, Illinois 61761, United States
  • Illinois CancerCare-Ottawa Clinic
    Ottawa, Illinois 61350, United States
  • Ottawa Regional Hospital and Healthcare Center
    Ottawa, Illinois 61350, United States
  • Illinois CancerCare-Pekin
    Pekin, Illinois 61554, United States
  • Pekin Cancer Treatment Center
    Pekin, Illinois 61554, United States
  • Methodist Medical Center of Illinois
    Peoria, Illinois 61603, United States
  • Proctor Hospital
    Peoria, Illinois 61614, United States
  • Illinois CancerCare-Peoria
    Peoria, Illinois 61615, United States
  • Illinois Oncology Research Association CCOP
    Peoria, Illinois 61615, United States
  • OSF Saint Francis Medical Center
    Peoria, Illinois 61637, United States
  • Illinois CancerCare-Peru
    Peru, Illinois 61354, United States
  • Illinois Valley Hospital
    Peru, Illinois 61354, United States
  • Illinois CancerCare-Princeton
    Princeton, Illinois 61356, United States
  • Perry Memorial Hospital
    Princeton, Illinois 61356, United States
  • SwedishAmerican Regional Cancer Center/ACT
    Rockford, Illinois 61107, United States
  • Memorial Medical Center
    Springfield, Illinois 62781-0001, United States
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
  • The Carle Foundation Hospital
    Urbana, Illinois 61801, United States
  • IU Health Arnett Cancer Care
    Lafayette, Indiana 47904, United States
  • Franciscan Saint Anthony Health-Michigan City
    Michigan City, Indiana 46360, United States
  • McFarland Clinic PC-William R Bliss Cancer Center
    Ames, Iowa 50010, United States
  • Ottumwa Regional Health Center
    Ottumwa, Iowa 52501, United States
  • Siouxland Hematology Oncology Associates
    Sioux City, Iowa 51101, United States
  • Mercy Medical Center-Sioux City
    Sioux City, Iowa 51104, United States
  • Saint Luke's Regional Medical Center
    Sioux City, Iowa 51104, United States
  • Lawrence Memorial Hospital
    Lawrence, Kansas 66044, United States
  • Wesley Medical Center
    Wichita, Kansas 67214, United States
  • Ochsner Health Center-Summa
    Baton Rouge, Louisiana 70809, United States
  • Ochsner Baptist Medical Center
    New Orleans, Louisiana 70115, United States
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
  • Greater Baltimore Medical Center
    Baltimore, Maryland 21204, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • Dana-Farber Harvard Cancer Center
    Boston, Massachusetts 02115, United States
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
  • Saint Joseph Mercy Hospital
    Ann Arbor, Michigan 48106-0995, United States

Showing the first 100 of 227 sites.

09

References and documents

Publications

  • Evens AM, Hong F, Habermann TM, Advani RH, Gascoyne RD, Witzig TE, Quon A, Ranheim EA, Ansell SM, Cheema PS, Dy PA, O'Brien TE, Winter JN, Cescon TP, Chang JE, Kahl BS. A Three-Arm Randomized Phase II Study of Bendamustine/Rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408. Clin Cancer Res. 2020 Sep 1;26(17):4468-4477. doi: 10.1158/1078-0432.CCR-20-1345. Epub 2020 Jun 12. PubMed 32532790 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 15, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01216683
Lead sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 7, 2010
Start date
Feb 9, 2011
Primary completion
Dec 2, 2019
Completion
Dec 2, 2019
Results posted
Feb 23, 2021
Last update
Jun 29, 2023

Study contacts

Andrew M. Evens, DO, MS
principal investigator · Robert H. Lurie Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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