Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

Refractory Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003620
• Other study ID #: NCI-2012-02280
• Secondary ID: CALGB-19805U10CA
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: January 16, 2013
• Start date: June 1999

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• B-cell Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Refractory Chronic Lymphocytic Leukemia
• Stage I Chronic Lymphocytic Leukemia
• Stage II Chronic Lymphocytic Leukemia
• Stage III Chronic Lymphocytic Leukemia
• Stage IV Chronic Lymphocytic Leukemia

Intervention

Drug:
• alvocidib
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Cancer and Leukemia Group B	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete + partial response rate	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	No
Secondary	Toxicity profile of flavopiridol	Toxicities will be tabulated by type and grade	Up to 5 years	No
Secondary	Progression-free survival	Will be estimated using the Kaplan-Meier method.	From onstudy date to the date of progression or death, assessed up to 5 years	No
Secondary	Overall survival		From onstudy date to the date of death, assessed up to 5 years	No