Clinical trial NCT00003620: Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia
Official title: A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-09-25
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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 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

Primary outcomes:
measure: Complete + partial response rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Toxicity profile of flavopiridol
timeFrame: Up to 5 years
measure: Progression-free survival
timeFrame: From onstudy date to the date of progression or death, assessed up to 5 years
measure: Overall survival
timeFrame: From onstudy date to the date of death, assessed up to 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cancer and Leukemia Group B
state: Illinois
Study officials:
affiliation: Cancer and Leukemia Group B
name: John Byrd
role: PRINCIPAL_INVESTIGATOR
References: