Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as thalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Combining fludarabine with thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell chronic lymphocytic leukemia.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With Chronic Lymphocytic Leukemia|
- Overall Responders (Complete and Partial Response) [ Time Frame: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years ]Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)
- Duration of Response [ Time Frame: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years ]
|Study Start Date:||May 2002|
|Study Completion Date:||May 2012|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Dose escalation
Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days
Drug: fludarabine phosphate
Given IVDrug: thalidomide
- Determine the safety and efficacy of fludarabine and thalidomide in patients with newly diagnosed B-cell chronic lymphocytic leukemia.
- Determine the overall response rate (complete and partial) in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
OUTLINE: This is an open-label, phase I, dose-escalation study of thalidomide followed by a phase II study.
- Phase I: Beginning on day 1, patients receive oral thalidomide once daily for up to 6 months. Beginning on day 7, patients also receive fludarabine IV over 30 minutes daily for 5 days. Treatment with fludarabine repeats every 28-35 days for up to 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of thalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive fludarabine and thalidomide as in phase I at the MTD.
Patients are followed at 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years.
PROJECTED ACCRUAL: Up to 45 patients (≥ 9 for the phase I portion and ≤ 36 for the phase II portion) will be accrued for this study within 8 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096018
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Kelvin Lee, MD||Roswell Park Cancer Institute|