drugset / Trial / NCT03932643

ONC-201 Maintenance Therapy in Acute Myeloid Leukemia and Myelodysplastic Syndrome After Stem Cell Transplant

NCT03932643

Phase 1 Completed 20 enrolled University of Nebraska
NaSingle-groupOpen-labelTreatment

Summary

This is a single-center Phase 1 trial of 20 patients with AML/MDS. Eligible patients will be enrolled following an informed consent between 6-20 weeks after allogeneic hematopoietic stem cell transplant. Patients will receive weekly oral ONC 201 for a total of 52 weeks.

Timeline

Start
2019-07-30
Primary completion
2025-03-27
Completion
2025-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Dordaviprone Small molecule 250 mg Oral
Subject Dordaviprone Small molecule 500 mg Oral
Subject Dordaviprone Small molecule 625 mg Oral