Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML

Recruiting now · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

This investigator-initiated, single-arm, phase II trial is aimed to evaluate the efficacy and safety of a venetoclax-based, anthracycline-free regimen in patients with newly diagnosed CBFβ::MYH11-positive acute myeloid leukemia.

Key facts

Study ID

NCT06429098

Run by

The First Affiliated Hospital of Soochow University

People needed

40

Starts

2024-01-01

Expected to finish

2027-12-31

Last updated by the study team

2025-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults ≥ 18 years.
• Newly diagnosed CBFβ::MYH11(+) AML.
• Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale.
• Subject must voluntarily sign and date an informed consent, prior to the initiation of any screening or study-specific procedures.
• Ferrara's criteria are used to determine whether a patient is unfit, and a patient is deemed unfit if at least one of the following criteria is met:
• Age>75 years.
• There are serious underlying heart, lung, kidney, liver complications.
• There are active infections that do not respond to anti-infective therapy.
• There is cognitive impairment.
• Other comorbidities that the doctor determines are not suitable for intensive chemotherapy.

You may not qualify if…

• Subject has received treatment with a hypomethylating agent and/or other chemotherapeutic agents either conventional or experimental or targeted drug therapy for AML (except oral hydroxyurea and/or leukocytometry to reduce white blood cell count).
• Pregnant or lactating women.
• To the knowledge of the subject and investigator, subject may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or be unable to comply with the required study procedures.
• Other conditions deemed unsuitable for participation in this study by the investigator.

Where it is running

• Ethical Committee of the First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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