Phase 3Recruiting
Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2
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
- Sponsor
- University of Ulm (Academic or other)
- Enrolment
- 650 planned
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Venetoclax; Placebo; Standard chemotherapy; Allogeneic stem cell transplantation
- Ages
- adults, older adults
- Registry
- NCT04628026
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Event Free Survival (EFS)
- Frequency of dose-limiting toxicities (DLTs) during the observation period (Primary safety endpoint during dose-finding phase)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered