Actively Recruiting

Phase 2
Age: 14Years - 60Years
All Genders
NCT06635681

Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-13

380

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients. Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival. Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy. Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.

CONDITIONS

Official Title

Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML

Who Can Participate

Age: 14Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of AML according to WHO (2022) or AML and MDS/AML defined by ICC standards
  • Age between 14 and 60 years, male or female
  • Eastern Oncology Collaboration Group physical status (ECOG-PS) score of 0-2
  • Laboratory tests within 7 days before treatment showing:
    • Total bilirubin no more than 1.5 times the normal upper limit for age
    • AST and ALT no more than 2.5 times the normal upper limit for age
    • Blood creatinine less than 2 times the normal upper limit for age
    • Myocardial enzymes less than 2 times the normal upper limit for age
    • Left ventricular ejection fraction greater than 50% by echocardiogram
  • Signed informed consent by patient or immediate family/legal guardian
Not Eligible

You will not qualify if you...

  • Acute promyelocytic leukemia with PML-RARA fusion gene
  • Acute myeloid leukemia with BCR-ABL fusion gene
  • Previously treated patients, except those who received hydroxyurea or cytarabine to reduce tumor burden
  • Concurrent malignant tumors of other organs requiring treatment
  • Active heart disease, including:
    • Uncontrolled or symptomatic angina
    • Myocardial infarction within 6 months prior to enrollment
    • History of arrhythmia requiring drug treatment or severe symptoms
    • Uncontrolled or symptomatic congestive heart failure greater than NYHA level 2
  • Serious infectious diseases such as untreated tuberculosis or pulmonary aspergillosis
  • Any condition making the patient unsuitable for the study as determined by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

H

Hui Wei, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML | DecenTrialz