RecruitingPhase 2NCT06635681

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

Efficacy of Venetoclax Combined with Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia : a Multi-center, Single-arm Clinical Trial


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

1,200 participants

Start Date

Sep 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 14 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing venetoclax, a targeted drug that blocks a cancer-survival protein, combined with intensive chemotherapy for younger and middle-aged adults with newly diagnosed acute myeloid leukemia (AML), a serious blood cancer. Venetoclax is already used with milder chemotherapy in older patients, and this study tests whether it can improve outcomes when paired with stronger regimens in people who can tolerate them. **You may be eligible if...** - You are between 14 and 60 years old with newly diagnosed AML (not previously treated) - Your physical status is good (ECOG 0–2) - Your heart function, liver function, and kidney function meet minimum levels - You have given informed consent (or a legal guardian has, if needed) **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a specific subtype) or AML with BCR-ABL fusion - You have previously received treatment for AML (except white blood cell-reducing drugs like hydroxyurea) - You have active heart disease (angina, recent heart attack, significant arrhythmia, or heart failure) - You have a serious active infection (like tuberculosis or aspergillosis) - You have another active cancer requiring treatment at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcombined chemotherapy

Induction therapy(1 cycle): Daunorubicin 60mg/m2/d d1-3 Cytarabine 100mg/m2/d d1-7 Venetoclax 100mg d-2, 200mg d-1, 400mg d1-7 If the first course of treatment did not result in CR, patients with therapeutic target could be treated with targeted drugs, and the patients without targets would be treated with HAV regimen: Cytarabine 100mg/m2/d, d1-5, Homoharringtonine 2mg/m2 d1-5, Venetoclax 100mg d-2, 200mg d-1, 400mg d1-7. Consolidation therapy(3 cycles): Cytarabine 2g/m2 q12h d1-3 Venetoclax 400mg d1-7 For patients with CBF and CEBPA dual mutations, the dose of cytarabine is 3g/m2. Maintenance treatment(6 cycles): Azacitidine 75mg/m2/d d1-5 Venetoclax 400mg d1-7 Allogeneic hematopoietic stem cell transplantation is recommended for high-risk groups and intermediate-risk with positive measurable residual disease.


Locations(1)

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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NCT06635681


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