drugset / Trial / NCT04628026
Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2
Phase 3
Recruiting
650 enrolled
University of Ulm
Stichting Hemato-Oncologie voor Volwassenen Nederland · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2
Timeline
- Start
- 2022-09-13
- Primary completion
- 2029-03
- Completion
- 2032-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | — | — |
| Background | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 500 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 1500 mg/m2 | Intravenous |
| Background | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |