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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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 →Frequently asked questions
Is NCT05834244 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hypomethylating agent, BCL2 inhibitor, MCL1 inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages