Status:
COMPLETED
Trial of Bendamustine, Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Celgene Corporation
Cephalon
Conditions:
Chronic Lymphocytic Leukemia
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is for subjects with a B-cell lymphoid malignancy (lymphoma) or chronic lymphocytic leukemia (CLL) that has come back after or did not get better with previous treatment. The purpose of thi...
Detailed Description
This is a Phase I, open-label, dose-escalation study of bendamustine and lenalidomide (BL) and also bendamustine,lenalidomide, and rituximab (BLR) in relapsed/refractory CLL and relapsed/refractory B-...
Eligibility Criteria
Inclusion
- Documented relapsed or refractory B-cell NHL; CD-20 positive tumor. Indolent NHL: follicular B-cell lymphoma, diffuse small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, transformed aggressive lymphomas, mantle cell lymphoma and chronic lymphocytic leukemia
- Maximum of 6 prior chemotherapy regimens. Prior rituximab is allowed.
- Bidimensionally measurable disease
- ECOG performance status 0-2
- Absolute neutrophil count \>/= 1000 and platelet count \>/= 50,000
- Serum creatinine \</= 1.5 mg/dL
- Adequate hepatic function
- Estimated life expectancy of at least 3 months
- All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the requirements of RevAssist
- Able to take aspirin 81 mg daily as prophylactic anticoagulation
Exclusion
- Chemotherapy or immunotherapy within 3 weeks prior to entering study or failure to recover from adverse events due to any agents administered previously
- Use of investigational agents within 28 days of study
- Hematopoietic growth factors within 14 days of study
- History of prior high dose chemotherapy with allogeneic stem cell support
- History of prior radioimmunotherapy \</= 1 year
- Concurrent treatment with therapeutic doses of systemic steroids
- Pregnant or lactating female subjects
- Concurrent, active malignancy other than lymphoma or CLL
- Primary CNS lymphoma
- Patients with a prior diagnosis of lymphoma active in the CNS are eligible only if CNS has been treated, and they are neurologically stable with no progressive symptoms off steroids and anti-convulsants
- Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of study objectives
- Hypersensitivity to murine proteins or to any component of rituximab
- Known positive for HIV or infectious hepatitis type C; hepatitis type B that is active and uncontrolled
- Hypersensitivity to mannitol
- Evidence of laboratory tumor lysis syndrome by Cairo-Bishop criteria
- Subject with recent thromboembolic event (deep vein thrombosis or pulmonary embolism) unless clinically stable and event occurred more than 2 weeks prior to enrollment.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00864942
Start Date
February 1 2009
End Date
October 1 2014
Last Update
March 13 2015
Active Locations (1)
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1
Georgetown University Hospital/Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007