A Pilot Study of Arsenic Trioxide-Based Consolidation Therapy for the Primary Treatment of Acute Promyelocytic Leukemia
- Determine, preliminarily, the safety of incorporating arsenic trioxide (ATO) into
cytarabine and daunorubicin hydrochloride-based consolidation therapy followed by
tretinoin maintenance therapy in patients receiving induction tretinoin and
daunorubicin hydrochloride with acute promyelocytic leukemia (APL) induced into
remission with tretinoin and daunorubicin hydrochloride.
- Determine, preliminarily, the efficacy of this strategy in inducing and maintaining
molecular remissions in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
- Induction therapy: Patients receive oral tretinoin twice daily on days 1-60 and
daunorubicin hydrochloride IV on days 4, 6, and 8. Patients are evaluated between days
60-67 and proceed to consolidation therapy.
- Consolidation therapy: Patients receive cytarabine IV continuously on days 1-3,
daunorubicin hydrochloride IV on days 1-3, and arsenic trioxide IV over 1-2 hours once
daily, 5 days a week, beginning on day 8 and continuing for 6 weeks. Patients with
clinical and/or cytogenic, but not molecular, remission receive additional arsenic
trioxide once daily, 5 days a week, for 30 doses (6 weeks). Patients achieving clinical
and molecular remission after completion of 6 or 12 weeks of arsenic trioxide proceed
to maintenance therapy.
- Maintenance therapy: Patients receive oral tretinoin once daily on days 1-15. Treatment
repeats every 3 months for 8 courses (2 years).
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Primary Purpose: Treatment
Disease-free survival at 2 and 5 years after study completion
Steven D. Gore, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15236|
|Comprehensive Cancer Center at University of Alabama at Birmingham||Birmingham, Alabama 35294|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|
|Blood and Marrow Transplant Group of Georgia||Atlanta, Georgia 30342-1601|