All-trans Retinoic Acid, and Arsenic +/- Idarubicin
Acute Promyelocytic Leukemia
About this trial
This is an interventional treatment trial for Acute Promyelocytic Leukemia focused on measuring Acute Promyelocytic Leukemia, APL, ATRA, All-Trans Retinoic Acid, Arsenic Trioxide, Theophylline, Gemtuzumab
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene by cytogenetics, PCR, or POD test.
- Provision of written informed consent.
- Patients in whom therapy for APL was initiated on an emergent basis are eligible
Exclusion Criteria:
- First trimester of pregnancy (ATRA is teratogenic)
- Corrected QT (QTC) interval must not be greater than 480 milliseconds.
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Induction ATRA + ATO + Idarubicin
Maintenance
Induction ATRA + ATO + GO
All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO) ATRA 45 mg/m2 daily by mouth beginning day 1; ATO 0.15 mg/kg by vein daily beginning on day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days starting on day 1.
All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO) ATO 0.15 mg/kg by vein over 2 hours Monday-Friday for 4 weeks, then a 4-week break. ATRA 45 mg/m2 by mouth every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.
All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO) + Gemtuzumab Ozogamicin (GO) ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1; ATO 0.15 mg/kg IV daily beginning on day 1; GO 9 mg/m2 on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1. Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.