OncoMatch/Clinical Trials/NCT05834244
A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)
Is NCT05834244 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Azacitidine and Venetoclax for acute myeloid leukemia.
Treatment: Azacitidine · Venetoclax · NK Cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Allowed: FLT3 actionable mutation
Allowed: IDH1 actionable mutation
Allowed: IDH2 actionable mutation
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: induction chemotherapy (7+3 based) — relapsed/refractory
7+3 based induction: 2 cycles for patients <60 years, and 1 cycle for patients who are either ≥60 years or unfit for intensive therapy
Must have received: induction regimen containing intermediate dose or higher of cytarabine (cytarabine) — relapsed/refractory
1 cycle of induction regimen containing intermediate dose or higher of cytarabine
Must have received: venetoclax with HMA/LDAC +/- other agents (venetoclax) — relapsed/refractory
2 cycles of venetoclax with HMA/LDAC +/- other agents
Must have received: hypomethylating agent — relapsed/refractory
4 cycles of HMA alone
Cannot have received: hypomethylating agent
Exception: for MDS only, if received prior to AML diagnosis
had not received prior hypomethylating agent, BCL2 inhibitors, MCL1 inhibitors, chemotherapy (definitive or therapeutic intent), or allo-SCT for MDS
Cannot have received: BCL2 inhibitor
Exception: for MDS only, if received prior to AML diagnosis
had not received prior hypomethylating agent, BCL2 inhibitors, MCL1 inhibitors, chemotherapy (definitive or therapeutic intent), or allo-SCT for MDS
Cannot have received: MCL1 inhibitor
Exception: for MDS only, if received prior to AML diagnosis
had not received prior hypomethylating agent, BCL2 inhibitors, MCL1 inhibitors, chemotherapy (definitive or therapeutic intent), or allo-SCT for MDS
Cannot have received: chemotherapy
Exception: for MDS only, if received prior to AML diagnosis
had not received prior hypomethylating agent, BCL2 inhibitors, MCL1 inhibitors, chemotherapy (definitive or therapeutic intent), or allo-SCT for MDS
Cannot have received: allogeneic stem cell transplant
Exception: for MDS only, if received prior to AML diagnosis
had not received prior hypomethylating agent, BCL2 inhibitors, MCL1 inhibitors, chemotherapy (definitive or therapeutic intent), or allo-SCT for MDS
Lab requirements
Kidney function
creatinine clearance ≥ 30 mL/min calculated by the Cockcroft-Gault formula or measured by 24-hour urine collection
Liver function
direct bilirubin ≤ 2 x ULN unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT ≤ 2.5 x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT ≤ 3 x ULN will be considered eligible
Adequate hepatic function (direct bilirubin ≤ 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT ≤ 2.5 x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT ≤ 3 x ULN will be considered eligible.) Adequate renal function with creatinine clearance ≥ 30 mL/min calculated by the Cockcroft-Gault formula or measured by 24-hour urine collection
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Case Western Reserve University · Cleveland, Ohio
- M.D. Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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