Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia

Stopped early · Phase 2

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia

In brief

This phase II trial is studying how well flavopiridol works in treating patients with chronic lymphocytic leukemia or prolymphocytic leukemia. Drugs used in chemotherapy, such as flavopiridol, 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

NCT00098371

Run by

National Cancer Institute (NCI)

People needed

64

Starts

2005-04-01

Expected to finish

2012-11-01

Last updated by the study team

2016-10-24

Who can join

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

You may qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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