Clinical trial · Interventional
Treatment Study for Children and Adolescents With Acute Promyelocitic Leukemia
NCT01226303CI-TRIAL-00025637unknownPhase 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)
This study is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR positive for the PML-RARα transcript or rarer retinoid sensitive subtypes (i.e. NPM-RAR-alpha, NuMA-RARalpha) and less than 21 years of age (for AIEOP, see appendix A).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATRA | Drug | Tretinoin | ALIAS |
| ATRA + IDA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- standard risk
- description
- are defined as those patients with a WBC less than 10x10 9 /L at presentation
- interventionNames
- Drug: ATRA
- type
- ACTIVE_COMPARATOR
- label
- high risk
- description
- are defined as those patients whose highest treatment WBC is equal to or greater than 10x10 9 /L at presentation
- interventionNames
- Drug: ATRA + IDA
Primary outcomes (1)
- measure
- • to conduct an international pediatric study for APL based on the GIMEMA-AIEOP/AIDA 93 protocol (the study from the Italian GIMEMA -AIEOP group which has produced the best results in children with APL to date), with optimal outcome and less toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a clinical diagnosis of initial APL and subsequently confirmed to have PML-RARα, NPM1-RARα or NUMA-RARα fusion. Whilst this study is only for ATRA-sensitive APL, APL is a hematological emergency and ATRA should be commenced as soon as the diagnosis is suspected. Study entry should not wait until the diagnosis of APL has been confirmed molecularly or cytogenetically * Less than 21 years of age at initial diagnosis (for AIEOP, see appendix A) * Considered suitable for anthracycline-based chemotherapy * Written informed consent available * Females of childbearing age must have a negative pregnancy test and subsequently must attempt to avoid pregnancy Exclusion Criteria: * Patients with a clinical diagnosis of APL but subsequently found to have PLZF-RARα fusion or lacking PML-RARα, NPM-RARα or NuMA-RARα rearrangement should be withdrawn from the study and treated on an alternative protocol. * Refractory/relapsed APL (the guidelines in this protocol for that subgroup are intended for patients treated from initial diagnosis according to this protocol) * Concurrent active malignancy * Pregnant or lactating * Physician and patient/guardian think that intensive chemotherapy is not an appropriate treatment option * Patients who have received alternative chemotherapy for 7 days or longer without ATRA for any reason (either APL not initially suspected or ATRA not available).
References
Publications (0)
Data not yet available
No reference posted for this study.