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
  Purpose

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


Condition Intervention Phase
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
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: June 1999
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: alvocidib
Given IV
Other Names:
  • FLAVO
  • flavopiridol
  • HMR 1275
  • L-868275
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003620

Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
Investigators
Principal Investigator: John Byrd Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003620     History of Changes
Other Study ID Numbers: NCI-2012-02280, CALGB-19805, U10CA031946, CDR0000066699
Study First Received: November 1, 1999
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Alvocidib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014