Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

January 23, 2018 updated by: Jeremy Abramson, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02214
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL
Time Frame: 2 year
2 year
Clinical efficacy
Time Frame: 2 years
response rate, progression-free and overall survival
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Jeremy Abramson, M.D., Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-016 (University of Köln)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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