drugset / Trial / NCT03031249
Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia
Phase 1/2
Enrolling by invitation
80 enrolled
Institute of Hematology & Blood Diseases Hospital, China
RandomizedParallel-groupOpen-labelTreatment
Summary
In this open-label, randomized, prospective clinical trial, nucleophosmin-1(NPM1) mutated acute myeloid leukemia (AML) patients who have reached CR are randomized into two groups.The control group receive high-dose cytarabine(HDAC) regimen while the experimental group receive high dose of cytarabine plus tretinoin(ATRA) and arsenic trioxide(ATO) treatment.The safety and efficacy of ATRA and ATO is evaluated.
Timeline
- Start
- 2017-02-08
- Primary completion
- 2026-05-15
- Completion
- 2027-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tretinoin | Small molecule | 30 mg/m2 | — |
| Subject | arsenic trioxide | Small molecule | 0.15 mg/kg | — |
| Background | Cytarabine | Small molecule | 3 g | — |