French Registry of First-line Treatment of Acute Promyelocytic Leukemia

Groupe Francophone des Myelodysplasies

Status

Active, not recruiting

Conditions

Acute Promyelocytic Leukemia

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02938858

French registry APL

Details and patient eligibility

About

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.

Full 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

Enrollment

400 estimated patients

Sex

All

Ages

Under 70 years old

Volunteers

No 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