Leukemia Clinical Trial
Official title:
A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth
of cancer cells and slow the growth of chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating
patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.
OBJECTIVES:
Primary
- Determine the complete and partial response rate in patients with
fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin
diftitox.
Secondary
- Determine the toxicity profile of this drug in these patients.
- Determine the response rate in patients (regardless of CD25 receptor density) treated
with this drug.
- Determine the progression-free survival and overall survival of patients treated with
this drug.
OUTLINE: This is a multicenter study.
Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 21
days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response after 8 courses proceed to follow-up. Patients
achieving a partial response or stable disease after 8 courses may continue treatment at the
discretion of the investigator.
Patients are followed every 3 months for 1 year and then annually until relapse.
PROJECTED ACCRUAL: A total of 12-44 patients will be accrued for this study within 1 year.
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