Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

This study is currently recruiting participants.
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01400685
First received: April 11, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
B Chronic Lymphocytic Leukemia
Drug: Lenalidomide
Drug: Bendamustine
Drug: Rituximab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • Clinical efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    response rate, progression-free and overall survival


Estimated Enrollment: 34
Study Start Date: December 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400685

Contacts
Contact: Christine Connolly 617-726-5131 cconnolly1@partners.org
Contact: Jeremy S Abramson, M.D. 617-726-8743 jabramson@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02214
Principal Investigator: Jeremy Abramson, M.D.         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Jennifer Brown, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Jeremy Abramson, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01400685     History of Changes
Other Study ID Numbers: 11-016
Study First Received: April 11, 2011
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
CLL
Leukemia
Untreated
B-CLL
SLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Rituximab
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014