A Phase I/II Trial of Infusional Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
OUTLINE: This is a dose-escalation study.
Patients receive arsenic trioxide IV over 2 hours daily for 28 days followed by a 14 day
rest period. Patients may receive up to 3 courses of treatment.
Dose escalation continues in cohorts of 3-6 patients until the maximum tolerated dose (MTD)
or minimum effective dose (MED) is determined. The MTD is defined as the dose preceding that
at which 2 or more patients experience dose limiting toxicity. The MED is defined as the
dose at which 4 of 6 patients achieve a complete cytogenetic or molecular response. After
the MTD or MED is determined, an additional 20 patients are enrolled at this dose level.
Patients are followed monthly for 6 months and every three months for an additional 1.5
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) or minimum effective dose (MED)
John F. DiPersio, MD, PhD
Washington University School of Medicine
United States: Food and Drug Administration
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