drugset / Trial / NCT06429449
Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia
Phase 1
Recruiting
30 enrolled
University of Colorado, Denver
The Leukemia and Lymphoma Society · collab
RandomizedSequentialOpen-labelTreatment
Summary
This is an open label, phase 1 study for AML subjects with relapsed or refractory disease or subjects in morphologic remission with MRD+ after first line therapy with venetoclax+HMA. A preliminary dose-finding cohort will be followed by 3 expansion cohorts.
Timeline
- Start
- 2024-07-21
- Primary completion
- 2026-12
- Completion
- 2027-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitoxantrone | Small molecule | 2 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 4 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 6 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 8 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 10 mg/m2 | Intravenous |
| Background | Azacitidine | Other / unclassified | — | — |
| Background | Venetoclax | Small molecule | — | — |