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TerminatedNCT02225275Updated Sep 28, 2022Results posted

Lenalidomide and Obinutuzumab in Treating Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 2 interventional study of Lenalidomide and Obinutuzumab in Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma and Refractory Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-28.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to slow accrual
Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial studies how well lenalidomide and obinutuzumab work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and obinutuzumab may work better in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

I. Overall response defined as achievement of complete response (CR) or partial response (PR).

SECONDARY OBJECTIVES:

I. Safety of the combination. II. Response according to prognostic markers at diagnosis. III. Time to next treatment. IV. Overall survival.

OUTLINE:

Patients receive obinutuzumab intravenously (IV) over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide orally (PO) once daily (QD) on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity.

02

Conditions studied

  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 9 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) 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

Inclusion criteria

  • Able to understand and to provide voluntarily informed consent
  • Have documented chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to National Cancer Institute (NCI) criteria
  • Recurrent or refractory disease according to NCI criteria
  • Patient are eligible if they have received one or more prior treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy > 6 months
  • Serum creatinine less or equal to 2 mg/dl
  • Total bilirubin less or equal to 2 mg/dl
  • Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) less or equal to two times the upper normal limit
  • Disease free of prior malignancies for 3 years with exception of currently treated basal cell squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast; patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received
  • No prior history of myelodysplastic syndrome or other myeloid malignancy
  • All participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the Revlimid REMS
  • Females of childbearing potential (FCBP) must have a negative serum and/or urine pregnancy test with a sensitive of at least 50 mIU/mL within 10-14 days and again within 24 hours prior to prescribe lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy

Exclusion criteria

Exclusion Criteria:

  • Known sensitivity to lenalidomide or other thalidomide derivatives or anti cluster of differentiation (CD)20
  • Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood)
  • Known history of infection with human immunodeficiency virus (HIV) or human T cell leukemia virus 1 (HTLV-1)
  • Serologic status reflecting active hepatitis B or C; patients with hepatitis B (HBV) antibody positive but who have positivity for hepatitis B surface antigen (HBsAg) or anti hepatitis B core antibody (anti-HBc) and patients who are positive for anti-hepatitis C (HCV) will need to have a negative polymerase chain reaction (PCR) (viral HBV deoxyribonucleic acid [DNA] or HCV ribonucleic acid [RNA]) result prior to enrollment; those who are HBsAg positive or HBV DNA positive and those who are positive for HCV (RNA) will be excluded
  • Pregnant or breast feeding females
  • History of tuberculosis treated within the last five years or recent exposure to tuberculosis
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject unacceptable risk if he/she were to participate to the study
  • Patients with a recent history of deep vein thrombosis or pulmonary embolus, in the six months prior to enrollment are not eligible for this study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Treatment (lenalidomide, obinutuzumab)

    Patients receive obinutuzumab IV over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide PO QD on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment with obinutuzumab repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity.

    Drug: Lenalidomide · Biological: Obinutuzumab

Interventions

  • DrugLenalidomide

    Given PO

    Also known as: CC-5013, CC5013, CDC 501, Revlimid

  • BiologicalObinutuzumab

    Given IV

    Also known as: Anti-CD20 Monoclonal Antibody R7159, GA-101, GA101, Gazyva, huMAB(CD20), R7159, RO 5072759

06

What researchers measure

Primary outcomes

  1. Number of Participants With a Response

    Response is Complete Response or Partial Response. CR is absence of Lymphadenopathy, Hepatomegaly or Splenomegaly, lymphocytes \< 4000/ul, normocellular, \<30% lymphocytes, no B-lymphoid nodules, Platelets \> 100,000/ul, hemoglobin \>11.0 g/dl and Neutrophils \>1500/ul. PR is \>/= 50% decrease in lymphadenopathy, hepatomegaly, splenomegaly and Blood Lymphocytes from baseline, 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count \> 100,000/ul, Hemoglobin \> 11 g/dl and Neutrophils \>1500/ul or increase \>/= 50% of all over base.

    Time frame: Up to 5 years

Secondary outcomes

  1. Time to Next Treatment

    The time-to-event outcomes (such as time to next treatment or overall survival). Time to Next Treatment is from start of study medication to the start of the next treatment, or last follow up if no next therapy.

    Time frame: Up to 5 years, 2 months

  2. Overall Survival

    Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.

    Time frame: Up to 5 years, 2 months

07

Results

Posted Sep 28, 2022

Participant flow

Recruitment Period: March 2016 to May 2021

Participant flow — Overall Study
MilestoneTreatment (Lenalidomide, Obinutuzumab)
Started9
Completed9
Not completed0

Outcome measures

PrimaryNumber of Participants With a Response

Response is Complete Response or Partial Response. CR is absence of Lymphadenopathy, Hepatomegaly or Splenomegaly, lymphocytes \< 4000/ul, normocellular, \<30% lymphocytes, no B-lymphoid nodules, Platelets \> 100,000/ul, hemoglobin \>11.0 g/dl and Neutrophils \>1500/ul. PR is \>/= 50% decrease in lymphadenopathy, hepatomegaly, splenomegaly and Blood Lymphocytes from baseline, 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count \> 100,000/ul, Hemoglobin \> 11 g/dl and Neutrophils \>1500/ul or increase \>/= 50% of all over base.

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Number of Participants With a Response
ParticipantsTreatment (Lenalidomide, Obinutuzumab)
Number of Participants With a Response5
SecondaryTime to Next Treatment

The time-to-event outcomes (such as time to next treatment or overall survival). Time to Next Treatment is from start of study medication to the start of the next treatment, or last follow up if no next therapy.

Time frame:
Up to 5 years, 2 months
Reported as:
Median · Months
Time to Next Treatment
MonthsTreatment (Lenalidomide, Obinutuzumab)
Time to Next Treatment26.9 (2.7 to 62)
SecondaryOverall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.

Time frame:
Up to 5 years, 2 months
Reported as:
Median · Months
Overall Survival
MonthsTreatment (Lenalidomide, Obinutuzumab)
Overall SurvivalNA (2.7 to 62)

Adverse events

Collected over Up to 5 years, 2 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Lenalidomide, Obinutuzumab)1/9 (11.1%)4/9 (44.4%)9/9 (100%)
Most frequent serious events
Most frequent serious events
EventTreatment (Lenalidomide, Obinutuzumab)
DyspneaRespiratory, thoracic and mediastinal disorders2/9
Febrile NeutropeniaBlood and lymphatic system disorders2/9
FeverGeneral disorders2/9
Chest PainCardiac disorders1/9
DehydrationMetabolism and nutrition disorders1/9
fallInjury, poisoning and procedural complications1/9
Respiratory FailureRespiratory, thoracic and mediastinal disorders1/9
Most frequent other events
Showing 10 of 29
Most frequent other events
EventTreatment (Lenalidomide, Obinutuzumab)
NeutropeniaInvestigations7/9
FatigueGeneral disorders4/9
NauseaGastrointestinal disorders4/9
FeverGeneral disorders3/9
ThrombocytopeniaInvestigations3/9
Alanine aminiotransferase increasedInvestigations2/9
Gastroesophageal Reflux DiseaseGastrointestinal disorders2/9
Infusion Related ReactionInjury, poisoning and procedural complications2/9
Peripheral Sensory NeuropathyNervous system disorders2/9
Alkaline Phosphatase IncreasedInvestigations1/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment (Lenalidomide, Obinutuzumab)
<=18 years0
Between 18 and 65 years2
>=65 years7
Age, Continuous
Age, Continuous(years)Treatment (Lenalidomide, Obinutuzumab)
Median69 (60 to 79)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Lenalidomide, Obinutuzumab)
Female4
Male5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Lenalidomide, Obinutuzumab)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White8
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Lenalidomide, Obinutuzumab)
United States9
08

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 29, 2019

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02225275
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 26, 2014
Start date
Mar 31, 2016
Primary completion
May 19, 2021
Completion
May 19, 2021
Results posted
Sep 28, 2022
Last update
Sep 28, 2022

Study contacts

Alessandra Ferrajoli
principal investigator · M.D. Anderson Cancer Center

Oversight

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

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