Skip to content
Bending the Curve Trial by Trial
?

AML17

Arsenic trioxide and all-trans retinoic acid treatment for acute promyelocytic leukaemia in all risk groups (AML17): a randomised, controlled, phase 3 trial

Phase 3N = 235

Population
Patients aged 16 years or older with APL confirmed by PML-RARA transcript, all risk groups (57 high-risk patients)
Design
Randomized, controlled, multicentre trial in 81 UK hospitals, 1:1 allocation by minimisation. Primary endpoint stated in the abstract: quality of life (EORTC QLQ-C30 global health status). High-risk patients (white blood cell count >10 × 10^9 per liter) could receive an initial dose of gemtuzumab ozogamicin. No maintenance or CNS prophylaxis in either group. Registered as ISRCTN55675535.
Arms
  • ATRA plus arsenic trioxide (experimental, n = 116): ATRA plus arsenic trioxide
  • ATRA plus idarubicin (control, n = 119): ATRA plus idarubicin (with mitoxantrone in course 3)
People
Burnett AK
Primary publication: Burnett AK, Russell NH, Hills RK, Bowen D, Kell J, Knapper S, et al. Arsenic trioxide and all-trans retinoic acid treatment for acute promyelocytic leukaemia in all risk groups (AML17): results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2015;16(13):1295-305. PubMedDOI

Appears in

Sources

  1. Burnett AK, Russell NH, Hills RK, Bowen D, Kell J, Knapper S, et al. Arsenic trioxide and all-trans retinoic acid treatment for acute promyelocytic leukaemia in all risk groups (AML17): results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2015;16(13):1295-305.

    PubMedDOI