drugset / Trial / NCT06384261
A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?
Timeline
- Start
- 2024-07-22
- Primary completion
- 2027-01
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cusatuzumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Background | Venetoclax | Small molecule | 400 mg | Oral |