Spots Global Cancer Trial Database for A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)

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Trial Identification

Brief Title: A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)

Official Title: A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)

Study ID: NCT05834244

Conditions

Acute Myeloid Leukemia

Interventions

Azacitidine

Venetoclax

NK Cells

Study Description

Brief 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.

Detailed 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 response * To estimate median time to negative MRD * To evaluate persistence of NK cells in peripheral blood * To explore biomarker of response and resistance * Using propensity-score matching analysis (per post-hoc plan) to explore the difference in response, survival adverse events in contemporary historical control population treated with HMA-VEN