Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | March 2004 |
CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
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 cells and either kill them or deliver cancer-killing substances to them
without harming normal cells. Combining lenalidomide with rituximab may kill more cancer
cells.
PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without
rituximab works in treating patients with relapsed or refractory chronic lymphocytic
leukemia.
immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab
can locate cancer cells and either kill them or deliver cancer-killing substances to them
without harming normal cells. Combining lenalidomide with rituximab may kill more cancer
cells.
PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without
rituximab works in treating patients with relapsed or refractory chronic lymphocytic
leukemia.
OBJECTIVES:
Primary
- Determine the best cytostatic response rate (including complete response, partial
response, or stable disease) in patients with relapsed or refractory chronic
lymphocytic leukemia treated with lenalidomide (CC-5013).
Secondary
- Determine the cytostatic response rate in patients who progress on CC-5013 and are then
treated with CC-5013 and rituximab.
- Determine the safety of these regimens in these patients.
- Determine time to progression in patients treated with these regimens.
OUTLINE: This is an open-label, non-randomized, pilot study.
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats
every 28 days for up to 12 courses in the absence of disease progression or unacceptable
toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond
CR.
Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab
IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all
subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of
further disease progression. Patients who achieve CR receive 2 additional courses beyond CR.
Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.
Primary
- Determine the best cytostatic response rate (including complete response, partial
response, or stable disease) in patients with relapsed or refractory chronic
lymphocytic leukemia treated with lenalidomide (CC-5013).
Secondary
- Determine the cytostatic response rate in patients who progress on CC-5013 and are then
treated with CC-5013 and rituximab.
- Determine the safety of these regimens in these patients.
- Determine time to progression in patients treated with these regimens.
OUTLINE: This is an open-label, non-randomized, pilot study.
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats
every 28 days for up to 12 courses in the absence of disease progression or unacceptable
toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond
CR.
Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab
IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all
subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of
further disease progression. Patients who achieve CR receive 2 additional courses beyond CR.
Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.
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
We found this trial at
1
site
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
Click here to add this to my saved trials
