Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

January 16, 2013 updated by: National Cancer Institute (NCI)

A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60606
        • Cancer and Leukemia Group B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: laboratory biomarker analysis
Correlative studies
Drug: alvocidib
Given IV
Other Names:
  • FLAVO
  • flavopiridol
  • HMR 1275
  • L-868275

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete + partial response rate
Time Frame: Up to 5 years
The CR + PR rate will be estimated with a 95% confidence interval, and the success of the study will be judged with the two-stage design given above.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity profile of flavopiridol
Time Frame: Up to 5 years
Toxicities will be tabulated by type and grade
Up to 5 years
Progression-free survival
Time Frame: From onstudy date to the date of progression or death, assessed up to 5 years
Will be estimated using the Kaplan-Meier method.
From onstudy date to the date of progression or death, assessed up to 5 years
Overall survival
Time Frame: From onstudy date to the date of death, assessed up to 5 years
From onstudy date to the date of death, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: John Byrd, Cancer and Leukemia Group B

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Primary Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 24, 2003

First Posted (Estimate)

September 25, 2003

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02280
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CALGB-19805
  • CDR0000066699 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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