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Lenalidomide and Obinutuzumab for Previously Untreated CLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02371590
Recruitment Status : Withdrawn (Study Not Activated Due to Contract Issues)
First Posted : February 25, 2015
Last Update Posted : February 23, 2018
Celgene Corporation
Genentech, Inc.
Information provided by (Responsible Party):
Michael Choi, University of California, San Diego

Brief Summary:
This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. This study will evaluate whether obinutuzumab and lenalidomide is safe and tolerable in this setting and induce complete clinical responses.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Lenalidomide Drug: Obinutuzumab Phase 2

Detailed Description:

This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. The primary endpoint is to determine safety and tolerability of the regimen and determine complete response (CR) to therapy. The secondary endpoints will assess the impact of treatment on progression free and overall survival

Eligible patients will receive obinutuzumab for 6 x 28 day cycles. Patients will also receive lenalidomide orally once daily on days 8-28 of each 28 day cycles. The starting dose for all patients is 5 mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, as tolerated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Trial To Evaluate Lenalidomide And Obinutuzumab For The Treatment Of Patients With Not Previously Treated Chronic Lymphocytic Leukemia
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: Lenalidomide-Obinutuzumab
All patients receive the combination of lenalidomide and obinutuzumab. There is no randomization or comparator arm.
Drug: Lenalidomide

Lenalidomide is administered orally once daily on Days 8-28 of each 28 day cycle. The starting dose for all patients is 5 mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, as tolerated.

The study consists of a 6 month treatment period with obinutuzumab and lenalidomide, and an indefinite period of treatment with lenalidomide for as long as it is helpful and tolerated by subject.

Other Name: Revlimid

Drug: Obinutuzumab
Obinutuzumab is administered as follows: Cycle 1: 100mg IV on day 1, 900 mg IV on day 2, 1000mg day 8, 1000 mg on day 15. Cycles 2-6: 1000mg IV on day 1.
Other Name: Gazyva

Primary Outcome Measures :
  1. The incidence of dose limiting toxicity [ Time Frame: 1 year ]
    For phase 1 portion of study

  2. Complete Response Rate [ Time Frame: 2 years ]
    For phase 2 portion of study: iwCLL 2008 defined complete response rate

Secondary Outcome Measures :
  1. Number of patients with adverse events associated with lenalidomide-obinutuzumab [ Time Frame: 2 years ]
  2. Progression free survival rate [ Time Frame: 2 years ]
    Progression free survival rate at completion of combination therapy, total progression free survival, and overall survival determined by International Working Group in CLL (iwCLL) criteria

  3. Overall response rate [ Time Frame: 2 years ]
    Overall response rate (Complete response + partial response) and stable disease rate (also based on 2008 iwCLL guidelines), also at the time of primary endpoint response assessment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Main Inclusion Criteria:

    1. Clinical and phenotypic verification of B cell CLL or SLL and measurable disease.
    2. Prior therapy: no prior CLL therapy.
    3. Patients must have progressive disease based on 2008 iwCLL definition with one of the following:
  • Symptomatic or progressive splenomegaly
  • Symptomatic lymph nodes, nodal clusters, or progressive lymphadenopathy
  • Progressive anemia (hemoglobin ≤ 11 g/dL)
  • Progressive thrombocytopenia (platelets ≤ 100 x 109/L)
  • Weight loss > 10% body weight over the preceding 6 month period
  • Fatigue attributable to CLL
  • Fever or night sweats for > 2 weeks without evidence of infection
  • Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of less than 6 months.
  • Able to take aspirin (81mg or 325mg) daily, warfarin, low molecular weight heparin, or equivalent anticoagulation as prophylactic medication.
  • All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of REMS.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to starting Revlimid and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program.
  • ECOG performance status of 0-2.
  • Adequate hematologic function
  • Adequate renal function
  • Adequate hepatic function

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Women for child-bearing age must obtain a pregnancy test and pregnant or breast feeding females are excluded.
  • Known hypersensitivity to thalidomide or lenalidomide (if applicable), including development of erythema nodosum or a desquamating rash while taking thalidomide or similar drugs.
  • Deep vein thrombosis or superficial thrombophlebitis of any cause on current anticoagulation therapy at the time of screening.
  • Patients who are currently receiving another investigational agent are excluded.
  • Current infection requiring parenteral antibiotics.
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV); or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) based on detectable viral load. Patients who are seropositive because of hepatitis B virus vaccine or passive immunization by intravenous immunoglobulin (IVIG) are eligible.
  • Active malignancy within the previous 2 years (other than completely resected non-melanoma skin cancer or carcinoma in situ).
  • Known central nervous system (CNS) involvement by malignancy.
  • Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
  • Insufficient recovery from surgical-related trauma or wound healing.
  • Impaired cardiac function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02371590

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United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Celgene Corporation
Genentech, Inc.
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Principal Investigator: Michael Choi, MD UC San Diego Moores Cancer Center

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Responsible Party: Michael Choi, Assistant Clinical Professor, University of California, San Diego Identifier: NCT02371590    
Other Study ID Numbers: 150342/161104
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Choi, University of California, San Diego:
Additional relevant MeSH terms:
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Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Immunologic Factors
Physiological Effects of Drugs
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Immunological