A Phase 2 interventional study of Bendamustine and Rituximab in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by University of Wisconsin, Madison. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-02.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).
The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
1,648 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 245 are open to participants now.
This study's enrollment of 34 is below the median of 40 across 1,356 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Drug: Bendamustine · Drug: Rituximab · Drug: Lenalidomide
90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Also known as: Treanda
375 mg/m2 Day 1 every 28 days for 6 cycles
Also known as: rituxan
5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
Also known as: revlimid, CC-5013
Progression Free Survival
The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Progression-free Survival
Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Objective Response Rate (Complete + Partial Responses)
Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Overall Survival
Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause.
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Research subjected from the University of Wisconsin and 7 Wisconsin Oncology Network institutions were enrolled from October 2009 to November 2011. Subjects were enrolled from outpatient hematology clinics at each participating institution.
| Milestone | Induction Chemoimmunotherapy + Maintenance Lenalidomide |
|---|---|
| Started | 34 |
| Completed | 19 |
| Not completed | 15 |
| Withdrew: Death | 2 |
| Withdrew: Lack of efficacy | 5 |
| Withdrew: Adverse event | 7 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | Induction Chemoimmunotherapy + Maintenance Lenalidomide |
|---|---|
| Started | 19 |
| Completed | 6 |
| Not completed | 13 |
| Withdrew: Lack of efficacy | 5 |
| Withdrew: Adverse event | 8 |
The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).
| months | Induction/Maintenance Chemotherapy |
|---|---|
| Progression Free Survival | 18.3 (10.6 to 24.3) |
Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.
| Proportion of participants | Induction/Maintenance Chemotherapy |
|---|---|
| 1-year progression-free survival | 0.62 (0.47 to 0.80) |
| 2-year progression-free survival | 0.35 (0.22 to 0.56) |
| 3-year progression-free survival | 0.23 (0.12 to 0.43) |
Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.
| participants | Complete Response (CR) | Partial Response (PR) | Stable Disease | Overall Response Rate |
|---|---|---|---|---|
| Objective Response Rate (Complete + Partial Responses) | 7 | 12 | 9 | 19 |
Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.
| participants | Induction Chemoimmunotherapy | Maintenance |
|---|---|---|
| Grade 3 leukopenia | 5 | 6 |
| Grade 4 leukopenia | 5 | 1 |
| Grade 3 neutropenia | 6 | 7 |
| Grade 4 neutropenia | 14 | 2 |
| Grade 3 anemia | 1 | 0 |
| Grade 3 thrombocytopenia | 5 | 1 |
| Grade 4 thrombocytopenia | 2 | 0 |
| Grade 3 febrile neutropenia | 4 | 1 |
| Grade 3 infection | 10 | 4 |
| Grade 4 infection | 1 | 1 |
| Grade 5 infection | 1 | 0 |
| Grade 3 fatigue | 2 | 0 |
| Grade 4 fatigue | 0 | 1 |
| Grade 3 nausea/emesis | 3 | 0 |
| Grade 3 serum transaminase levels (Gr 3/Gr 4) | 4 | 0 |
Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause.
| months | Overall Study Population |
|---|---|
| Overall Survival | 42.8 (33.7 to 69.5) |
Collected over Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Induction Chemoimmunotherapy | — | 14/34 (41.2%) | 34/34 (100%) |
| Maintenance | — | 8/19 (42.1%) | 19/19 (100%) |
| Event | Induction Chemoimmunotherapy | Maintenance |
|---|---|---|
| Grade 4 neutropeniaBlood and lymphatic system disorders | 14/34 | 2/19 |
| Grade 3 neutropeniaBlood and lymphatic system disorders | 6/34 | 7/19 |
| Grade 3 leukopeniaBlood and lymphatic system disorders | 5/34 | 6/19 |
| Grade 3 thrombocytopeniaBlood and lymphatic system disorders | 5/34 | 1/19 |
| Grade 4 leukopeniaBlood and lymphatic system disorders | 5/34 | 1/19 |
| Grade 3 febrile neutropeniaInfections and infestations | 4/34 | 1/19 |
| Grade 4 thrombocytopeniaBlood and lymphatic system disorders | 2/34 | 0/19 |
| Grade 4 infectionsInfections and infestations | 1/34 | 1/19 |
| Grade 3 thrombosisBlood and lymphatic system disorders | 0/34 | 1/19 |
| Second primary malignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/34 | 1/19 |
| Event | Induction Chemoimmunotherapy | Maintenance |
|---|---|---|
| Grade 1-2 fatigueGeneral disorders | 0/34 | 6/19 |
| Grade 1-2 musculoskeletal painMusculoskeletal and connective tissue disorders | 0/34 | 6/19 |
| Grade 3 InfectionsInfections and infestations | 10/34 | 4/19 |
| Grade 1-2 rashSkin and subcutaneous tissue disorders | 5/34 | 5/19 |
| Grade 1-2 nauseaGastrointestinal disorders | 0/34 | 4/19 |
| Grade 1-2 coughRespiratory, thoracic and mediastinal disorders | 0/34 | 4/19 |
| Grade 1-2 hyperglycemiaMetabolism and nutrition disorders | 0/34 | 4/19 |
| Grade 1-2 night sweatsGeneral disorders | 0/34 | 3/19 |
| Grade 1-2 headacheNervous system disorders | 0/34 | 3/19 |
| Grade 3 elevated AST/ALTHepatobiliary disorders | 4/34 | 0/19 |
Subjects with progressive chronic lymphocytic leukemia/small lymphocytic lymphoma receiving 1-5 prior unique treatment regimens.
| Age, Continuous(years) | Overall Study Population |
|---|---|
| Median | 67 (48 to 86) |
| Sex: Female, Male(Participants) | Overall Study Population |
|---|---|
| Female | 10 |
| Male | 24 |
| ECOG performance status(participants) | Overall Study Population |
|---|---|
| ECOG performance status 0-1 | 32 |
| ECOG performance status 2 | 2 |
| Disease staging(participants) | Overall Study Population |
|---|---|
| Rai stage 1/2 (CLL) | 12 |
| Rai stage 3/4 (CLL) | 14 |
| Ann Arbor stage 1/2 (SLL) | 1 |
| Ann Arbor 3/4 (SLL) | 7 |
| Median prior therapies(prior therapies) | Overall Study Population |
|---|---|
| Median | 2 (1 to 4) |
| Prior therapy with fludarabine(participants) | Overall Study Population |
|---|---|
| Prior fludarabine-based therapy | 23 |
| No previous fludrarabine exposure | 11 |
| Refractory to most recent therapy(participants) | Overall Study Population |
|---|---|
| Refractory to most recent therapy | 4 |
| Not refractory to most recent therapy | 30 |
| Elevated serum lactate dehydrogenase (LDH) level(participants) | Overall Study Population |
|---|---|
| Enrollment LDH elevated | 20 |
| Enrollment LDH not elevated | 14 |
2 further baseline measures are reported on the registry.
The record gives a start of Oct 2009, a primary completion of Jul 2013 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2017, 4 years after primary completion.
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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bendamustine · Rituximab · Lenalidomide
Leukemia, Lymphocytic, Chronic, B-Cell →
University of Wisconsin, Madison →