French Registry of First-line Treatment of Acute Promyelocytic Leukemia

Groupe Francophone des Myelodysplasies400 enrolled

Overview

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.

* 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 Type

OBSERVATIONAL

Enrollment

400

Conditions

Acute Promyelocytic Leukemia

Eligibility

Sex: ALLMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (27)

Centre Hospitalier d'Aix en Provence

Aix-en-Provence, France

Outcomes

Primary Outcomes

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

Rate of hematological complete remission

from date of inclusion until end of induction therapy

Time frame: up to 30 days

Rate of overall survival

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

Time frame: at 5 years

Data from ClinicalTrials.gov

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