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OncoMatch/Clinical Trials/NCT05566054

Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia

Is NCT05566054 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Chidamide and Azacitidine for acute monocytic leukemia.

Phase 2RecruitingThe First Affiliated Hospital of Soochow UniversityNCT05566054Data as of May 2026

Treatment: Chidamide · Azacitidine · VenetoclaxThis study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Performance status

ECOG 0–3(Limited self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiotherapy

Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before enrollment

Cannot have received: chemotherapy

Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before enrollment

Cannot have received: targeted therapy

Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before enrollment

Cannot have received: hematopoietic stem cell transplantation

Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before enrollment

Lab requirements

Kidney function

Creatinine clearance >= 30 mL/min to < 45 mL/min (inclusion); Exclusion: serum creatinine > 1.5 × ULN

Liver function

Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × ULN (inclusion); Exclusion: total bilirubin > 1.5 × ULN, ALT/AST > 2.5 × ULN or > 1.5 × ULN with liver involvement

Cardiac function

Cardiac history of congestive heart failure requiring treatment or ejection fraction <= 50% or chronic stable angina (inclusion); Exclusion: QTc prolongation (male > 450 ms; female > 470 ms), ventricular tachycardia, atrial fibrillation, II-degree heart block, MI within 1 year, congestive heart failure, symptomatic coronary heart disease requiring treatment

Cardiac history of congestive heart failure requiring treatment or ejection fraction <= 50% or chronic stable angina. Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × ULN. Creatinine clearance >= 30 mL/min to < 45 mL/min. Liver function abnormalities (total bilirubin > 1.5 × ULN, ALT/AST > 2.5 × ULN or with liver involvement ALT/AST > 1.5 × ULN), or renal anomalies (serum creatinine > 1.5 × ULN).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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