Lenalidomide and Obinutuzumab for Previously Untreated CLL

NCT ID: NCT02371590

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide-Obinutuzumab

All patients receive the combination of lenalidomide and obinutuzumab. There is no randomization or comparator arm.

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

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.

Obinutuzumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Revlimid; Gazyva

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Michael Choi

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Choi, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego Moores Cancer Center

Locations

UC San Diego Moores Cancer Center

La Jolla, California, United States

Countries

United States

Other Identifiers

150342/161104

Identifier Type: -

Identifier Source: org_study_id