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

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02938858

Enrollment

400

Registered

2016-10-19

Start date

2015-10-01

Completion date

2026-07-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Promyelocytic Leukemia

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPierre FENAUX, MD

French APL Cooperative Group

Outcome results