drugset / Trial / NCT05904106
Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML
Phase 2
Recruiting
146 enrolled
Technical University Dresden
AbbVie · collabUniversity Hospital Heidelberg · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase II clinical trial evaluates the efficacy and tolerability of the non-intensive treatment with venetoclax and the hypomethylating agent azacitidine as compared to the standard of care chemotherapy plus gemtuzumab ozogamicin in newly diagnosed NPM1 mutated AML patients fit for intensive chemotherapy.
Timeline
- Start
- 2024-04-07
- Primary completion
- 2028-09
- Completion
- 2028-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 3000 mg/m2 | Intravenous |
| Subject | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |
| Comparator | Gemtuzumab Ozogamicin | Monoclonal antibody | 3 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |