Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia
B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria: Histologically diagnosed intermediate risk (stage I or II) or high risk (stage III or IV) refractory B-cell chronic lymphocytic leukemia Intermediate risk group must have evidence of active disease as shown by at least one of the following: Massive or progressive splenomegaly and/or lymphadenopathy Weight loss of greater than 10% in the last 6 months CALGB grade 2-4 fatigue Fevers greater than 100.5 degree Fahrenheit OR night sweats for greater than2 weeks without evidence of infection Progressive lymphocytosis with an increase greater than 50% over a 2 month period or an anticipated doubling time of less than 6 months Refractory to fludarabine treatment OR relapsed within 6 months of fludarabine Lymphocytosis greater than 5000/mm3 at some time during disease Bilirubin no greater than 1.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN Not pregnant or nursing Fertile patients must use effective contraception No more than 1 prior nonradiolabeled antibody treatment (e.g., Campath-1H or rituximab) At least 1, but no more than 3, prior chemotherapy regimens At least 1 prior chemotherapy regimen comprising fludarabine No other concurrent chemotherapy No concurrent chronic use of oral corticosteroids No concurrent hormone therapy except for non-disease related conditions No concurrent dexamethasone or other corticosteroid-based antiemetics No concurrent palliative radiotherapy
Sites / Locations
- Cancer and Leukemia Group B
Arms of the Study
Arm 1
Experimental
Treatment (flavopiridol)
Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3. Treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable toxicity. Patients registered after 9/15/2000 receive flavopiridol IV over 1 hour daily on days 1-3. Treatment repeats every 3 weeks for a total of 8 courses in the absence of disease progression or unacceptable toxicity.