Clinical trial · Interventional
All-trans Retinoic Acid, and Arsenic +/- Idarubicin
Treatment of Acute Promyelocytic Leukemia (APL) With All-Trans Retinoic Acid, and Arsenic +/- Idarubicin
NCT00413166CI-TRIAL-00038481completedPhase 2Results postedClinicalTrials.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 goal of this clinical research study is to learn if the combination of arsenic trioxide (ATO) with ATRA and possibly idarubicin is effective in treating patients with newly-diagnosed APL.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| All-Trans Retinoic Acid (ATRA) | Drug | Tretinoin | ALIAS |
| Arsenic Trioxide (ATO) | Drug | Arsenic Trioxide | ALIAS |
| Gemtuzumab Ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
| Idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Induction ATRA + ATO + Idarubicin
- description
- All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO) ATRA 45 mg/m2 daily by mouth beginning day 1; ATO 0.15 mg/kg by vein daily beginning on day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days starting on day 1.
- interventionNames
- Drug: All-Trans Retinoic Acid (ATRA)
- Drug: Arsenic Trioxide (ATO)
- Drug: Idarubicin
- type
- EXPERIMENTAL
- label
- Maintenance
- description
- All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO) ATO 0.15 mg/kg by vein over 2 hours Monday-Friday for 4 weeks, then a 4-week break. ATRA 45 mg/m2 by mouth every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.
- interventionNames
- Drug: All-Trans Retinoic Acid (ATRA)
- Drug: Arsenic Trioxide (ATO)
- Drug: Idarubicin
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene by cytogenetics, PCR, or POD test. 2. Provision of written informed consent. 3. Patients in whom therapy for APL was initiated on an emergent basis are eligible Exclusion Criteria: 1. First trimester of pregnancy (ATRA is teratogenic) 2. Corrected QT (QTC) interval must not be greater than 480 milliseconds.
References
Publications (0)
Data not yet available
No reference posted for this study.