Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

NCT ID: NCT01400685

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-01-31

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.

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.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; B Chronic Lymphocytic Leukemia

Study Design

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

Interventions

Lenalidomide

Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.

Intervention Type: DRUG

Bendamustine

90 mg/m\^2 IV days 1-2 of each cycle for 6 cycles

Intervention Type: DRUG

Rituximab

375 mg/m\^2 IV day 1 (cycle 1), 500 mg/m\^2 day 1 (cycles 2-6)

Intervention Type: DRUG

Other Intervention Names

CC-5013; Revlimid; Treanda; SDX 105; Rituxan; Mabthera

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeremy Abramson, MD

Director, Lymphoma Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeremy Abramson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-016

Identifier Type: -

Identifier Source: org_study_id