Leukemia Clinical Trial
Official title:
A Phase I/II Open-Label Study Of The Intravenous Administration Of Homoharringtonine (CGX-635) Salvage Therapy For The Treatment Of Refractory Acute Promyelocytic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of homoharringtonine in treating
patients who have refractory acute promyelocytic leukemia.
OBJECTIVES:
- Determine the safety of salvage therapy comprising homoharringtonine in patients with
refractory acute promyelocytic leukemia.
- Determine the antileukemic efficacy of this drug in these patients.
OUTLINE: Patients receive remission induction therapy comprising homoharringtonine (HH) IV
continuously on days 1-14. Courses repeat every 4 weeks in the absence of unacceptable
toxicity until a complete remission (CR) is achieved or the patient fails to respond after 3
courses.
Patients who achieve a CR during induction therapy receive maintenance therapy comprising HH
IV continuously on days 1-7. Maintenance treatment repeats every 4 weeks for a total of 12
courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.
;
Primary Purpose: Treatment
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