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


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete + partial response rate

Outcome Description:

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.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

John Byrd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02280

NCT ID:

NCT00003620

Start Date:

June 1999

Completion Date:

Related Keywords:

  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606