French Registry of First-line Treatment of Acute Promyelocytic Leukemia

• Conditions: Acute Promyelocytic Leukemia

• Registration Number: NCT02938858
• Lead Sponsor: Groupe Francophone des Myelodysplasies

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.

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

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-09-22
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-17
• Last Update Submitted: 2016-10-17
• Study First Posted: 2016-10-19
• Last Update Posted: 2016-10-19
• Primary Completion: 2020-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival	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 Outcome Measures

Name	Time	Method
Rate of hematological complete remission	up to 30 days	from date of inclusion until end of induction therapy
Rate of overall survival	at 5 years

Trial Locations

Locations (27)

Centre Hospitalier d'Aix en Provence; 🇫🇷 Aix en Provence, France

Groupe Hospitalier SUD; 🇫🇷 Amiens, France

Centre Hospitalier V. Dupouy; 🇫🇷 Argenteuil, France

Hôpital Jean Minjoz; 🇫🇷 Besançon, France

CHU Bordeaux Pellegrin enfant; 🇫🇷 Bordeaux, France

CHRU de Brest - Pédiatrie Spécialisée; 🇫🇷 Brest, France

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Hopital Andre Mignot; 🇫🇷 Le Chesnay, France

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