French Registry of First-line Treatment of Acute Promyelocytic Leukemia

The registry aims to compare the two first-line available treatment approaches in non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.

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Key information

Conditions

Acute Promyelocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Neoplasms Neoplasms by Histologic Type

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier d'Aix en Provence, Aix-en-Provence, France

About this study

Collection of epidemiological data on non-high-risk APL patients aged ≤ 70 years: age and sex distribution, medical history, prognostic factors (time to treatment start, severity of coagulopathy at presentation, Performance status…).
Documentation of clinical and biologic effectiveness of the two first-line treatment approaches available for non-high-risk APL patients.
Documentation of Minimal Residual Disease (MRD).
Correlation of clinical outcomes with the chosen therapy.
Validation of published prognostic factors and identification of new prognostic factors

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newly-diagnosed APL (either de novo or therapy-related) based on cytologic criteria and confirmed by the presence of the t(15;17) translocation and/or by the detection of the fusion transcript PML/RARα.
Non-high-risk APL (White Blood Count < 10000/μl at presentation)
Age ≤ 70 years

Exclusion criteria

Relapsed APL
Newly-diagnosed High-risk APL (White Blood Count > 10000/μl at presentation)
Age > 70 years

Treatment and study plan

Primary outcomes

Event-free survival

Time frame: From date of induction until the date of first documented event, assessed up to 60 months

events are: no achievement of haematological complete remission after induction therapy; no achievement of molecular remission after the consolidation courses; relapse; death including early death

Secondary outcomes

Rate of hematological complete remission

Time frame: up to 30 days

from date of inclusion until end of induction therapy
Rate of overall survival

Time frame: at 5 years

Overall survival defined as the time from inclusion until death or end of follow-up

Sponsors and collaborators

Lead sponsor

Groupe Francophone des Myelodysplasies

Other

Collaborators

Teva Pharmaceuticals USA

Registry information

Official study title

The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years

Important dates

Study start: 2015
Primary completion: 2026
Study completion: 2026
First posted: Oct 19, 2016
Registry last updated: Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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