Alvocidib in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Stopped early · Phase 1

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Contiguous Stage II Small Lymphocytic Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage I Small Lymphocytic Lymphoma, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage III Small Lymphocytic Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Small Lymphocytic Lymphoma

In brief

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, such as alvocidib, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Key facts

Study ID

NCT00377104

Run by

National Cancer Institute (NCI)

People needed

24

Starts

2006-09-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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