French Registry of First-line Treatment of Acute Promyelocytic Leukemia
The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years
1 other identifier
observational
400
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 22, 2016
CompletedFirst Posted
Study publicly available on registry
October 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
December 11, 2025
March 1, 2025
10.8 years
September 22, 2016
December 4, 2025
Conditions
Outcome Measures
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
From date of induction until the date of first documented event, assessed up to 60 months
Secondary Outcomes (2)
Rate of hematological complete remission
up to 30 days
Rate of overall survival
at 5 years
Study Arms (2)
ATRA-chimio
according to usual practice center
ATRA-ATO
according to usual practice center
Eligibility Criteria
French patients with newly-diagnosed de novo or therapy-related non-high-risk APL (White Blood Count \< 10000/μl) aged ≤ 70 years.
You may qualify if:
- 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
You may not qualify if:
- Relapsed APL
- Newly-diagnosed High-risk APL (White Blood Count \> 10000/μl at presentation)
- Age \> 70 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teva Pharmaceuticals USAcollaborator
- Groupe Francophone des Myelodysplasieslead
Study Sites (27)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre FENAUX, MD
French APL Cooperative Group
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2016
First Posted
October 19, 2016
Study Start
October 1, 2015
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
December 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share