Leukemia Clinical Trial
Official title:
A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have
recurrent or refractory acute lymphocytic leukemia.
OBJECTIVES:
- Assess the complete remission rate in patients with recurrent or refractory non-T-cell
acute lymphocytic leukemia when treated with 506U78.
- Determine the frequency and severity of toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21
days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6
months for 3.5 years.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18
months.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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