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OncoMatch/Clinical Trials/NCT07078591

Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML

Is NCT07078591 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute myeloid leukemia.

Phase 2RecruitingBeijing 302 HospitalNCT07078591Data as of May 2026

Treatment: GPBMC infusion · Venetoclax · Azacitidine (AZA) · Daunorubicin · Idarubicin(IDA) · Cytarabine (Ara-C)The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Prior therapy

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

Cannot have received: anti-acute leukemia treatment

Exception: prior hydroxyurea and/or leukapheresis are permitted

Lab requirements

Kidney function

serum creatinine <= 2 × ULN or CrCl >= 40 mL/min

Liver function

ALT and AST <= 3 × ULN, total bilirubin <= 1.5 × ULN

Cardiac function

LVEF > 50% by echocardiogram; no clinically significant cardiovascular disease (e.g., uncontrolled/highly symptomatic arrhythmias, CHF, MI within 6 months, NYHA class 3 or 4)

Adequate hepatic function including ALT and AST <= 3 × ULN, and total bilirubin <= 1.5 × ULN. Adequate renal function including serum creatinine <= 2 × ULN or CrCl >= 40mL/min. LVEF measured by echocardiogram is within the normal range (LVEF > 50%). Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or NYHA function class 3 (moderate) or class 4 (severe) heart disease [excluded].

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

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