French Registry of First-line Treatment of Acute Promyelocytic Leukemia

NCT ID: NCT02938858

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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* 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

Conditions

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Acute Promyelocytic Leukemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ATRA-chimio

according to usual practice center

No interventions assigned to this group

ATRA-ATO

according to usual practice center

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Francophone des Myelodysplasies

OTHER

Sponsor Role lead

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre FENAUX, MD

Role: PRINCIPAL_INVESTIGATOR

French APL Cooperative Group

Locations

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Centre Hospitalier d'Aix en Provence

Aix-en-Provence, , France

Site Status

Groupe Hospitalier SUD

Amiens, , France

Site Status

Centre Hospitalier V. Dupouy

Argenteuil, , France

Site Status

Hôpital Jean Minjoz

Besançon, , France

Site Status

CHU Bordeaux Pellegrin enfant

Bordeaux, , France

Site Status

CHRU de Brest - Pédiatrie Spécialisée

Brest, , France

Site Status

CHU Estaing

Clermont-Ferrand, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

Hopital Andre Mignot

Le Chesnay, , France

Site Status

CH Dr Schaffner

Lens, , France

Site Status

Chru - Hopital Claude Huriez

Lille, , France

Site Status

Hôpital universitaire Dupuytren

Limoges, , France

Site Status

Institut Paoli Calmettes

Marseille, , France

Site Status

Chu Timone

Marseille, , France

Site Status

CHR Metz-Thionville - Hôpital de Marcy

Metz, , France

Site Status

CHU Saint Eloi

Montpellier, , France

Site Status

CHU Hôtel Dieu

Nantes, , France

Site Status

Hôpital de la Source

Orléans, , France

Site Status

Hôpital TROUSSEAU

Paris, , France

Site Status

Hôpital Necker

Paris, , France

Site Status

Hôpital Robert Debré

Paris, , France

Site Status

CHU Hôpital Sud - service Hémato-oncologie Pédiatrique

Rennes, , France

Site Status

Hôpital V. Provo

Roubaix, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Institut de Cancerologie de La Loire

Saint-Priest-en-Jarez, , France

Site Status

IUCT Oncopole

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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French registry APL

Identifier Type: -

Identifier Source: org_study_id

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