A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA
alvocidib
+ laboratory biomarker analysis
Chronic Disease+13
+ Hematologic Diseases
+ Hemic and Lymphatic Diseases
Treatment Study
Summary
Study start date: June 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the complete and partial response rate to flavopiridol in patients with fludarabine-refractory chronic lymphocytic leukemia. Assess the toxicity profile of this treatment in these patients. Examine progression-free survival and overall survival following this treatment in these patients. Determine the effects of flavopiridol on normal T-cell subsets and immunoglobulin levels in these patients. OUTLINE: This is an open label, multicenter study. 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. Patients are followed every 3 months for the first year and then every 6 months for 5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.37 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location