Trial intelligence / Profile preview

ATO Combined to ATRA and Idarubicin Versus Standard ATRA and Anthracyclines-based Chemotherapy for High-risk APL

NCT02688140Phase 3

Key facts

Status: Completed
Start: Jun 2016
Primary completion: Jan 2025
Countries: 5
Sponsor: Technische Universität Dresden
Modality: DNA Intercalators/Alkylators

Drugs: arsenic trioxide
Conditions: acute promyelocytic leukemia (APL)

Overview

Phase 3, randomised, open-label trial of arsenic trioxide in acute promyelocytic leukemia (APL) (2 arms), sponsored by Technische Universität Dresden. Primary endpoint: Event-free survival at 66 months. Started Jun 2016; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Arm A
Induction: IDA + ATRA + ATO. Consolidation: ATRA + ATO.
Arm B (standard chemotherapy)
Induction: IDA + ATRA. Consolidation: IDA + Ara-C + ATRA + MTZ. Maintenance: 6-MP + MTX + ATRA.

Who it enrols

Adults aged 18-65 with newly diagnosed, high-risk acute promyelocytic leukemia (WBC > 10 GPt/l), adequate organ function, and no severe cardiac or pulmonary disease.

Endpoints

Primary

Event-free survival66 months

Secondary

Hematological complete remission60 days
Early death30 days
Overall survival2 years
Cumulative incidence of secondary MDS or AML66 months
Cumulative incidence of relapse2 years
Incidence of hematological and non-hematological toxicity30 months
Molecular remission256 days
PML/RARa transcript level reduction30 months

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