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RECRUITINGPhase 2INTERVENTIONAL

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

Study of A Venetoclax-based, Anthracycline-free Regimen in Patients With Newly Diagnosed CBFβ::MYH11-positive Acute Myeloid Leukemia

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adults ≥ 18 years. 2. Newly diagnosed CBFβ::MYH11(+) AML. 3. Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale. 4. Subject must voluntarily sign and date an willing to sign a consent form, 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: 1. Age\>75 years. 2. There are serious underlying heart, lung, kidney, liver complications. 3. There are active infections that do not respond to anti-infective therapy. 4. There is cognitive impairment. 5. Other comorbidities that the doctor determines are not suitable for intensive chemotherapy. Who Should NOT Join This Trial: 1. 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). 2. Pregnant or lactating women. 3. 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. 4. Other conditions deemed unsuitable for participation in this study by the investigator. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Adults ≥ 18 years. 2. Newly diagnosed CBFβ::MYH11(+) AML. 3. Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale. 4. 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: 1. Age\>75 years. 2. There are serious underlying heart, lung, kidney, liver complications. 3. There are active infections that do not respond to anti-infective therapy. 4. There is cognitive impairment. 5. Other comorbidities that the doctor determines are not suitable for intensive chemotherapy. Exclusion Criteria: 1. 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). 2. Pregnant or lactating women. 3. 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. 4. Other conditions deemed unsuitable for participation in this study by the investigator.

Treatments Being Tested

DRUG

Venetoclax

Given PO, once daily. Treatment in cycle 1, the dose is 100 mg on day 1, then ramp up to 400mg. In all subsequent cycles, the dose of venetoclax is initiated at 400 mg daily.

DRUG

azacitidine

Given SC

DRUG

decitabine

Given IV

DRUG

Cytarabine

Given IV

Locations (2)

Ethical Committee of the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China