Leukemia Clinical Trial
Official title:
A Phase I/II Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With 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.
OBJECTIVES:
- 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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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