Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01400685

Collaborator

Dana-Farber Cancer Institute (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias.

In this research study we are hoping to learn more about the effects of lenalidomide on CLL when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma B Chronic Lymphocytic Leukemia	Drug: Lenalidomide Drug: Bendamustine Drug: Rituximab	Phase 1

Detailed Description

Subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4 weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on day 1 of each cycle.

Subjects will receive routine blood tests and physical exam during each cycle. Tumor assessments by CT scan will be performed during cycles 2, 4, and 6.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jan 1, 2018

Outcome Measures

Primary Outcome Measures

Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL [2 years]

Secondary Outcome Measures

Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL [2 year]
Clinical efficacy [2 years]
response rate, progression-free and overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with B-cell CLL or SLL (chronic lymphocytic leukemia or small lymphocytic leukemia)
Life expectancy > 3 months
Organ and marrow function with protocol parameters
Able to take aspirin daily

Exclusion Criteria:

Age >80 years
Prior systemic therapy for CLL/SLL including chemotherapy or antibody therapy
Pregnant or breast-feeding
Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent
Known hypersensitivity to thalidomide or lenalidomide
Prior use of lenalidomide
Concurrent use of other anti-cancer agents or treatments
HIV positive
Prior history of another malignancy unless disease free for at least 2 years
Uncontrolled intercurrent illness