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RecruitingPhase 2NCT06429098

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

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

40 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • 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.

Exclusion Criteria4

  • 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.

Interventions

DRUGVenetoclax

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.

DRUGazacitidine

Given SC

DRUGdecitabine

Given IV

DRUGCytarabine

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

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NCT06429098

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