Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
B-cell Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria: Histologically confirmed B-cell chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL) arising from CLL No de novo PLL Lymphocyte count > 5,000/mm^3 at some point since initial diagnosis of CLL B-cells co-expressing CD5 AND CD19 or CD20 If no dim serum immunoglobulin or CD23 expression on leukemia cells, must be examined for cyclin D1 overexpression OR t(11;14) to rule out mantle cell lymphoma Requiring therapy, defined by any of the following: Massive or progressive splenomegaly and/or lymphadenopathy Anemia (hemoglobin < 11 g/dL) OR thrombocytopenia (platelet count < 100,000/mm^3) Weight loss > 10% within the past 6 months Grade 2 or 3 fatigue Fevers > 100.5°C or night sweats for > 2 weeks with no evidence of infection Progressive lymphocytosis with an increase of > 50% over a 2-month period OR an anticipated doubling time < 6 months Received ≥ 1 prior chemotherapy regimen that included fludarabine or nucleoside equivalent OR alternative therapy if contraindication to fludarabine exists (i.e., autoimmune hemolytic anemia) Performance status - ECOG 0-2 More than 2 years See Disease Characteristics Baseline cytopenias allowed WBC ≤ 200,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease, hemolysis, or disease infiltration of the liver) AST ≤ 2 times ULN (unless due to hemolysis or disease infiltration of the liver) Creatinine ≤ 2.0 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy that would limit life expectancy See Disease Characteristics No other concurrent chemotherapy No concurrent chronic corticosteroids or corticosteroids as antiemetics No concurrent hormonal therapy except steroids for new adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes) No concurrent radiotherapy
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (alvocidib)
Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.