Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003620
First received: November 1, 1999
Last updated: January 16, 2013
Last verified: January 2013

November 1, 1999
January 16, 2013
June 1999
June 2006   (final data collection date for primary outcome measure)
Complete + partial response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00003620 on ClinicalTrials.gov Archive Site
  • Toxicity profile of flavopiridol [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Toxicities will be tabulated by type and grade
  • Progression-free survival [ Time Frame: From onstudy date to the date of progression or death, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be estimated using the Kaplan-Meier method.
  • Overall survival [ Time Frame: From onstudy date to the date of death, assessed up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia
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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
  • Drug: alvocidib
    Given IV
    Other Names:
    • FLAVO
    • flavopiridol
    • HMR 1275
    • L-868275
  • Other: laboratory biomarker analysis
    Correlative studies
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.

Interventions:
  • Drug: alvocidib
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
Not Provided
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003620
NCI-2012-02280, CALGB-19805, U10CA031946, CDR0000066699
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: John Byrd Cancer and Leukemia Group B
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP