OncoMatch/Clinical Trials/NCT06532552

Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Acute Myeloid Leukemia

Is NCT06532552 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including VACl and VACh for acute myeloid leukemia, adult.

Phase 2RecruitingThe First Affiliated Hospital of Soochow UniversityNCT06532552Data as of May 2026

Treatment: VACl · VACh · VACl Alternating With VACh · VA — This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible for intensive therapy or declining. Cladribine is a purine analogue widely used in hematologic malignancies. The monocytic leukemia stem cell is selective sensitivity to Cladribine. Chidamide, a newly designed selective histone deacetylase inhibitor, could down regulate myeloid cell leukaemia 1 (MCL1) expression in Venetoclax resistant AML cells. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Excluded: BCR ABL1 translocation

CML with or without BCR-ABL1 translocation, BCR/ABL positive AML

Excluded: ABL1 BCR fusion

CML with or without BCR-ABL1 translocation, BCR/ABL positive AML

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: venetoclax (venetoclax)

Prior therapy with venetoclax

Cannot have received: purine analog (cladribine)

Prior therapy with Cladribine

Cannot have received: hypomethylating agent

Prior therapy with hypomethylating agents (HMAs)

Cannot have received: histone deacetylase inhibitor (chidamide)

Prior therapy with Chidamide

Cannot have received: CAR-T cell therapy

Prior therapy with Chimeric Antigen Receptor T cell therapy

Cannot have received: experimental therapy

Prior therapy with experimental therapies for MDS or AML

Lab requirements

Kidney function

creatinine≤1.5xULN

Liver function

bilirubin≤2mg/dL, AST and/or ALT≤3 x ULN (unless due to leukemic infiltration)

liver function (bilirubin≤2mg/dL, aspartate transaminase (AST) and/or alanine transaminase (ALT)≤3 x ULN). Unless liver enzyme abnormalities are determined by the treating MD and PI to be due to leukemic infiltration. kidney function (creatinine≤1.5xULN )

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

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