drugset / Trial / NCT05287568
CC-486 and Venetoclax for Acute Myeloid Leukemia
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.
Timeline
- Start
- 2022-12-19
- Primary completion
- 2027-03-23
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 200 mg | Oral |
| Subject | Azacitidine | Other / unclassified | 300 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |