Leukemia Clinical Trial
Official title:
A Phase II Study of Arsenic Trioxide for Induction Therapy of Adult Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia and Previously Untreated Chronic Myeloid Leukemia With Blast Crisis
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 arsenic trioxide in treating patients
who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous
leukemia.
OBJECTIVES:
- Determine the rate of clinical and hematologic response in patients with Philadelphia
chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously
untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when
treated with arsenic trioxide.
- Determine the duration of hematologic response and overall survival of these patients
when treated with this regimen.
- Determine the pattern of clinical adverse experience in these patients when treated
with this regimen.
- Determine the pharmacokinetic profile of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond
may receive a second course of therapy beginning 28 days from the last dose of the first
course.
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3
months thereafter.
PROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5
years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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