Clinical trial · Interventional
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
NCT04793919CI-TRIAL-00076028recruitingPhase 2ClinicalTrials.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)
The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| All-trans retinoic acid | Drug | Tretinoin | ALIAS |
| Arsenic Trioxide | Drug | Arsenic Trioxide | ALIAS |
| Mylotarg | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Risk (SR)
- description
- Patient with APL and WBC less than 10x10e9/L at presentation before start treatment
- interventionNames
- Drug: Arsenic Trioxide
- Drug: All-trans retinoic acid
- type
- EXPERIMENTAL
- label
- High Risk (HR)
- description
- Patient with APL, with the highest pre-treatment WBC count equal to or greater than 10x10e9/L at presentation
- interventionNames
- Drug: Mylotarg
- Drug: Arsenic Trioxide
- Drug: All-trans retinoic acid
Primary outcomes (1)
- measure
- Event Free Survival (EFS) probability
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene * Age \<18 years * Written informed consent by parents or legal guardians Exclusion Criteria: * Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol * Significant liver dysfunction (bilirubin serum levels \>3 mg/dL, ALT/AST serum levels greater than 5 times the normal values) * Creatinine serum levels \>2 times the normal value for age * Significant arrhythmias, EKG abnormalities (\*see below), other cardiac contraindications (L-FEV \<50% or LV-FS \<28%) * Neuropathy * Concurrent active malignancy * Uncontrolled life-threatening infections * Pregnant or lactating female * Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available
References
Publications (0)
Data not yet available
No reference posted for this study.