drugset / Trial / NCT03932318
Venetoclax, Azacitidine, and Lintuzumab-Ac225 in AML Patients
NaSingle-groupOpen-labelTreatment
Summary
The study is a multicenter, open label Phase I/II trial. 1. To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 when given in combination with venetoclax and azacitidine for patients with CD33 positive AML. (Phase I portion) 2. To assess the percentage of patients with CR, CRh, CRi, MLFS or Overall Response (CR + CRh + CRi + MLFS), up to 6 months after the start of treatment without receiving other AML therapies.. (Phase 2 portion)
Timeline
- Start
- 2023-03
- Primary completion
- 2023-12
- Completion
- 2024-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 0.25 unknown | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 0.5 unknown | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 1 unknown | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 1.5 unknown | — |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Background | Venetoclax | Small molecule | 400 mg | Oral |