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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


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

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