Brief Title
French Registry of First-line Treatment of Acute Promyelocytic Leukemia
Official Title
The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years
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
Study Type
Observational [Patient Registry]
Primary Outcome
Event-free survival
Secondary Outcome
Rate of hematological complete remission
Condition
Acute Promyelocytic Leukemia
Study Arms / Comparison Groups
ATRA-chimio
Description: according to usual practice center
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
400
Start Date
October 2015
Completion Date
October 2022
Primary Completion Date
October 2020
Eligibility Criteria
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
Gender
All
Ages
N/A - 70 Years
Accepts Healthy Volunteers
No
Contacts
Pierre FENAUX, MD, +33 1 71 20 70 18, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02938858
Organization ID
French registry APL
Responsible Party
Sponsor
Study Sponsor
Groupe Francophone des Myelodysplasies
Collaborators
Teva Pharmaceuticals USA
Study Sponsor
Pierre FENAUX, MD, Principal Investigator, French APL Cooperative Group
Verification Date
October 2016