Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

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: NCT01400685
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : January 25, 2018
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital

April 11, 2011
July 22, 2011
January 25, 2018
December 2012
December 2017   (Final data collection date for primary outcome measure)
Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01400685 on Archive Site
  • Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL [ Time Frame: 2 year ]
  • Clinical efficacy [ Time Frame: 2 years ]
    response rate, progression-free and overall survival
Same as current
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Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
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.

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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • B Chronic Lymphocytic Leukemia
  • Drug: 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.
    Other Names:
    • CC-5013
    • Revlimid
  • Drug: Bendamustine
    90 mg/m^2 IV days 1-2 of each cycle for 6 cycles
    Other Names:
    • Treanda
    • SDX 105
  • Drug: Rituximab
    375 mg/m^2 IV day 1 (cycle 1), 500 mg/m^2 day 1 (cycles 2-6)
    Other Names:
    • Rituxan
    • Mabthera
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Jeremy Abramson, MD, Massachusetts General Hospital
Massachusetts General Hospital
Dana-Farber Cancer Institute
Principal Investigator: Jeremy Abramson, M.D. Massachusetts General Hospital
Massachusetts General Hospital
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP