Status:
TERMINATED
Alvocidib in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
B-cell Chronic Lymphocytic Leukemia
Contiguous Stage II Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, s...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the toxicity profile, dose-limiting toxicity, and maximum tolerated dose of flavopiridol (alvocidib) as consolidation chemotherapy after cytoreduction chemotherapy in...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of 1 of the following:
- B-cell chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Must have received 1-3 prior therapies for CLL
- Completed therapy 2-12 months ago
- Prior therapy must have led to a partial response or greater
- No evidence of progressive disease
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,000/mm³
- WBC ≤ 5,000/mm³
- Platelet count ≥ 50,000/mm³
- Cytopenia allowed
- Creatinine \< 2.0 mg/dL
- Bilirubin ≤ 1.5 times normal (unless due to Gilbert's disease or hemolysis)
- AST ≤ 2 times normal (unless due to hemolysis)
- No secondary malignancy or other disease that would limit survival to \< 2 years
- No history of inflammatory bowel disease unless inactive for \> 2 years
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- See Disease Characteristics
- No other concurrent chemotherapy
- No concurrent radiotherapy
- No concurrent dexamethasone or other corticosteroid-based antiemetics
- No concurrent chronic corticosteroid therapy
- No other concurrent hormonal therapy except for the following:
- Steroids for new adrenal failure
- Hormones for nondisease-related conditions (e.g., insulin for diabetes)
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00377104
Start Date
September 1 2006
Last Update
July 2 2013
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210