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
- 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
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
Safety by physical examinations, vital signs, laboratory studies (routine hematology, clinical chemistry, pharmacokinetics, urinalysis, chest x-ray, and EKG), and solicited and unsolicited adverse events
Jorge Cortes, MD
M.D. Anderson Cancer Center
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|