Clinical trial · Observational
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
NCT02938858CI-TRIAL-00098838completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Promyelocytic Leukemia | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- ATRA-chimio
- description
- according to usual practice center
- label
- ATRA-ATO
- description
- according to usual practice center
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
- From date of induction until the date of first documented event, assessed up to 60 months
- description
- 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 outcomes (2)
- measure
- Rate of hematological complete remission
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.