Status:
COMPLETED
Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 myel...
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 subse...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01400685
Start Date
December 1 2012
End Date
January 1 2018
Last Update
January 25 2018
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215