NCT05834244

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine	Given by IV (vein)
DRUG	Venetoclax	Given by PO
DRUG	NK Cells	Given by IV (vein)

Timeline

• Start date: 2023-10-26
• Primary completion: 2026-06-30
• Completion: 2028-06-30
• First posted: 2023-04-28
• Last updated: 2026-03-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study