Clinical trial · Interventional
Acute Promyelocytic Leukemia 2006 (APL)
A Randomized Trial Assessing the Role of Arsenic Trioxide and/or ATRA During Consolidation Course in Newly Diagnosed Acute Promyelocytic Leukemia (APL)
NCT00378365CI-TRIAL-00014264unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the role of Arsenic trioxide and/or ATRA during consolidation course in APL. It is hoped that the investigational arms will further increase the event-free survival at 2 years, with reduced toxicity and without increasing the relapse rate by comparison with a classical anthracycline-AraC consolidation regimen.
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 |
|---|---|---|---|
| Leukemia, Promyelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic trioxide | Procedure | — | UNRESOLVED |
| ATRA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Arsenic trioxide
- interventionNames
- Procedure: Arsenic trioxide
- Procedure: ATRA
Primary outcomes (2)
- measure
- For Patients aged 70 years or less with WBC<10.000/mm3, The primary end point will be event free survival at 2 years from CR achievement
- timeFrame
- during de study
- description
- For Patients aged 70 years or less with WBC\<10.000/mm3, The primary end point
- measure
- For patients older than 70 years with WBC>10.000 /mm3, The primary end point will be EFS at 2 years from diagnosis
- timeFrame
- during the study
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of APL based on morphological grounds, which will have to be confirmed by the presence of t(15;17) and/or PML-RARA rearrangement with characterization of the bcr subtype (PML-RAR characterization). * Untreated patients. * No contraindication to intensive chemotherapy (especially well documented cardiac contraindication to idarubicin). * In female patients: absence of pregnancy and adequate contraceptive methods (due to teratogenetic effects of ATRA in early pregnancy). * Absence of Hypersensitivity to Arsenic derivatives. * No QT interval prolongation or complete atria-ventricular block. * Written informed consent. Exclusion Criteria: * Patients already treated. * Patients with contraindication to intensive chemotherapy, especially well documented cardiac contraindication to Idarubicin. * In female patients: pregnancy or absence of adequate contraceptive Methods * QT interval prolongation or complete atria-ventricular block. * Hypersensitivity to Arsenic derivatives.
References
Publications (1)
- DERIVEDAdes L, Thomas X, Bresler AG, Raffoux E, Spertini O, Vey N, Marchand T, Recher C, Pigneux A, Girault S, Deconinck E, Gardin C, Tournilhac O, Lambert JF, Chevallier P, de Botton S, Lejeune J, Dombret H, Chevret S, Fenaux P. Arsenic trioxide is required in the treatment of newly diagnosed acute promyelocytic leukemia. Analysis of a randomized trial (APL 2006) by the French Belgian Swiss APL group. Haematologica. 2018 Dec;103(12):2033-2039. doi: 10.3324/haematol.2018.198614. Epub 2018 Jul 19. PMID 30026341