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CompletedNCT02938858Updated Sep 11, 2026

French Registry of First-line Treatment of Acute Promyelocytic Leukemia

An observational study in Acute Promyelocytic Leukemia, sponsored by Groupe Francophone des Myelodysplasies. Completed at 27 sites in France. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Groupe Francophone des Myelodysplasies · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
Up to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description
  • 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
02

Conditions studied

  • Acute Promyelocytic Leukemia
03

Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

French patients with newly-diagnosed de novo or therapy-related non-high-risk APL (White Blood Count \< 10000/μl) aged ≤ 70 years.

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

Exclusion Criteria:

  • Relapsed APL
  • Newly-diagnosed High-risk APL (White Blood Count > 10000/μl at presentation)
  • Age > 70 years
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (actual)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • ATRA-chimio

    according to usual practice center

  • ATRA-ATO

    according to usual practice center

05

What researchers measure

Primary outcomes

  1. Event-free survival

    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

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

Secondary outcomes

  1. Rate of hematological complete remission

    from date of inclusion until end of induction therapy

    Time frame: up to 30 days

  2. Rate of overall survival

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

    Time frame: at 5 years

06

Study locations

27 sites
  • Centre Hospitalier d'Aix en Provence
    Aix-en-Provence, 13616, France
  • Groupe Hospitalier SUD
    Amiens, 80054, France
  • Centre Hospitalier V. Dupouy
    Argenteuil, 95107, France
  • Hôpital Jean Minjoz
    Besançon, 25030, France
  • CHU Bordeaux Pellegrin enfant
    Bordeaux, 33076, France
  • CHRU de Brest - Pédiatrie Spécialisée
    Brest, 29609, France
  • CHU Estaing
    Clermont-Ferrand, 63100, France
  • Hôpital Henri Mondor
    Créteil, 94100, France
  • CHU de Grenoble
    Grenoble, 38043, France
  • Hopital Andre Mignot
    Le Chesnay, 78150, France
  • CH Dr Schaffner
    Lens, 62307, France
  • Chru - Hopital Claude Huriez
    Lille, 59037, France
  • Hôpital universitaire Dupuytren
    Limoges, 87042, France
  • Institut Paoli Calmettes
    Marseille, 13273, France
  • Chu Timone
    Marseille, 13385, France
  • CHR Metz-Thionville - Hôpital de Marcy
    Metz, 57085, France
  • CHU Saint Eloi
    Montpellier, 34095, France
  • CHU Hôtel Dieu
    Nantes, 44035, France
  • Hôpital de la Source
    Orléans, 45100, France
  • Hôpital TROUSSEAU
    Paris, 75012, France
  • Hôpital Necker
    Paris, 75015, France
  • Hôpital Robert Debré
    Paris, 75019, France
  • CHU Hôpital Sud - service Hémato-oncologie Pédiatrique
    Rennes, 35203, France
  • Hôpital V. Provo
    Roubaix, 59056, France
  • Centre Henri Becquerel
    Rouen, 76038, France
  • Institut de Cancerologie de La Loire
    Saint-Priest-en-Jarez, 42270, France
  • IUCT Oncopole
    Toulouse, 31059, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02938858
Lead sponsor
Groupe Francophone des Myelodysplasies
Collaborators
Teva Pharmaceuticals USA
Responsible party
Sponsor
First posted
Oct 19, 2016
Start date
Oct 2015
Primary completion
Jul 2026
Completion
Jul 2026
Last update
Sep 11, 2026

Study contacts

Pierre FENAUX, MD
principal investigator · French APL Cooperative Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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