Phase 2
N=78
All-trans Retinoic Acid, and Arsenic +/- Idarubicin
Acute Promyelocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00413166 ↗Enrolled (actual)
78
Serious AEs
38.5%
Results posted
Apr 2019
Primary outcome: Primary: Complete Response (CR) Rate — 55; 5; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- All-Trans Retinoic Acid (ATRA) (Drug); Arsenic Trioxide (ATO) (Drug); Idarubicin (Drug); Gemtuzumab Ozogamicin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) Rate |
55; 5; 15 | — |
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.
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.