New Protocol: Arsenic Trioxide with ATRA for High-Risk APL

Randomized, open-label, multicenter, phase III study [APOLLO/NCT02688140]

Newly diagnosed high-risk acute promyelocytic leukemia

ATRA-ATO (n=68) vs ATRA-Chemotherapy (n=65)

2-yr EFS: 88% vs 71% (ATRA-ATO vs. ATRA-Chemo) (HR 0.4 [0.17-0.92], P=.02)

2-yr OS: 93% vs 87% (HR 0.6 [0.2-1.8])

Molecular relapse: 1.5% vs 12.3% (P=.014)

Grade >=3 AEs: 72% vs 92%

Serious AEs: 32% vs 68%

Febrile neutropenia: Not reported vs 20%

Reviewed by Ulas D. Bayraktar, MD on Sep 5, 2025