Phase 2
Completed N=78
All-trans Retinoic Acid, and Arsenic +/- Idarubicin
Source: ClinicalTrials.gov NCT00413166 ↗Enrolled (actual)
78
Serious AEs
38.5%
Results posted
Apr 2019
Primary outcomePrimary: Complete Response (CR) Rate — 55; 5; 15 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) Rate |
55; 5; 15 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene by cytogenetics, PCR, or POD test.
- Provision of written informed consent.
- Patients in whom therapy for APL was initiated on an emergent basis are eligible
Exclusion Criteria
- First trimester of pregnancy (ATRA is teratogenic)
- Corrected QT (QTC) interval must not be greater than 480 milliseconds.
Data sourced from ClinicalTrials.gov (NCT00413166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.