French Registry of First-line Treatment of Acute Promyelocytic Leukemia

Acute Promyelocytic Leukemia Clinical Trial

Official title: The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

• NCT number: NCT02938858
• Study type: Observational [Patient Registry]
• Source: Groupe Francophone des Myelodysplasies
• Contact: Pierre FENAUX, MD
• Phone: +33 1 71 20 70 18
• Email: pierre.fenaux@aphp.fr
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Completion date: October 2022