A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)
M.D. Anderson Cancer Center
Summary
To learn if adding a healthy person's natural killer (NK) cells to the combination of Azacitidine and Venetoclax can help to control AML. NK cells are cancer- and infection-fighting immune cells.
Description
Primary Objective: -To evaluate Safety of the combination of azacitidine, venetoclax and allogeneic NK cells Secondary Objective: * To estimate overall response rate (ORR) * To estimate rate of CR/CRi by 4 cycles of therapy * To estimate rate of MRD negative by 6 cycles * To estimate overall survival (OS) * To estimate relapse-free survival (RFS) Exploratory Objectives: * To estimate rate of CRc MRD negative at any time * To estimate event-free survival (EFS) * To estimate duration of response (DOR) * To estimate median time to blood count recovery * To estimate median time to first respo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients need to have a confirmed diagnosis of AML, or MDS/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.43,44 Dose escalation cohort: 2. Patients ≥18 years with R/R AML or R/R MDS/AML, other than acute promyelocytic leukemia (APL), or core binding factor (CBF) AML with no available standard treatment options. 3. Relapsed or refractory disease defined by standard criteria as follows 1. Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease fo…
Interventions
- DrugAzacitidine
Given by IV (vein)
- DrugVenetoclax
Given by PO
- DrugNK Cells
Given by IV (vein)
Locations (2)
- Case Western Reserve UniversityCleveland, Ohio
- M.D. Anderson Cancer CenterHouston, Texas