Status:
COMPLETED
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
Celgene
Conditions:
Leukemia
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cel...
Detailed Description
OBJECTIVES: Primary * Determine the best cytostatic response rate (including complete response, partial response, or stable disease) in patients with relapsed or refractory chronic lymphocytic leuke...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry
- Relapsed or refractory disease
- Measurable disease, defined by 1 of the following criteria:
- Absolute lymphocyte count ≥ 5,000/mm\^3
- Measurable lymphadenopathy or organomegaly
- Received ≥ 1 prior therapy for CLL
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 30,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
- Renal
- Creatinine ≤ 1.5 mg/dL
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation
- No known hypersensitivity to thalidomide
- No erythema nodosum characterized by a desquamating rash after prior thalidomide or similar drug administration
- No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins
- No serious medical condition or laboratory abnormality that would preclude study participation
- No psychiatric illness that would preclude giving informed consent
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior lenalidomide (CC-5013)
- No concurrent thalidomide
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- No concurrent radiotherapy
- Surgery
- Not specified
- Other
- At least 4 weeks since prior therapy for CLL
- At least 28 days since prior experimental drug or therapy
- No other concurrent anticancer therapies
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00096044
Start Date
March 1 2004
End Date
June 1 2015
Last Update
July 11 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001