Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia

In brief

Phase II trial to study the effectiveness of flavopiridol in treating patients who have chronic lymphocytic leukemia that has not responded to treatment with fludarabine. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

Key facts

Study ID

NCT00003620

Run by

National Cancer Institute (NCI)

People needed

37

Starts

1999-06-01

Last updated by the study team

2013-01-17

Who can join

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

You may qualify if…

• 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

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.