NCT02938858

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Promyelocytic Leukemia

Timeline

• Start date: 2015-10-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2016-10-19
• Last updated: 2025-12-11

Locations

27 sites across 1 country: France