CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
18 Years
N/A
Both
Leukemia
Trial Information
CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) at 6 months
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Kelvin Lee, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000391767
NCT ID:
NCT00096044
Start Date:
March 2004
Completion Date:
Related Keywords:
- Leukemia
- refractory chronic lymphocytic leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
