Leukemia Clinical Trial
Official title:
A Phase I/II Trial of Infusional Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
The purpose of this study is to evaluate both the efficacy and toxicity of infusional arsenic trioxide in the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APML). In addition, correlation between pharmacokinetic data and both therapeutic response and therapy-related toxicities will be sought.
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
years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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