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Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and Myelodysplastic Syndrome

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndromes

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
idarubicin
Cytarabine
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: aged 18-60 years had a confirmed diagnosis of previously untreated de novo acute myeloid leukaemia or high risk myelodysplastic syndrome by bone marrow examination according to the criteria presented by WHO. Eastern Cooperative Oncology Group performance status of 0-2. adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography. Exclusion Criteria: younger than 18 years old, or older than 60 years old. Diagnosed as acute promyelocytic leukaemia. Pretreated with anthracycline. CNS involvement. Positive for HIV, hepatitis B virus, or hepatitis C virus. New York Heart Association cardiovascular disability status higher than grade 2 (grade 2 is defined as cardiac disorder that is asymptomatic at rest, but ordinary physical activity might result in fatigue, palpitations, dyspnoea, or angina), chronic respiratory diseases requiring continuous supplementary oxygen, inability to take oral medication or malabsorption syndrome Uncontrollable systemic infection (viral, bacterial, or fungal), Inability to sign the informed consent form.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment group

    Arm Description

    Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy

    Outcomes

    Primary Outcome Measures

    CR
    assessment of the composite complete remission rate (CR=CR+CRi)

    Secondary Outcome Measures

    MRD
    assessment of bone marrow measurable residual disease by flow cytometry
    EFS
    Evaluate the event-free survival
    OS
    Evaluated the overall survival
    adverse events
    Monitor of adverse events

    Full Information

    First Posted
    April 13, 2023
    Last Updated
    September 18, 2023
    Sponsor
    First Affiliated Hospital of Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06050941
    Brief Title
    Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and Myelodysplastic Syndrome
    Official Title
    A Multi-center Prospective Single Arm Clinical Study of Reduced Intensive 3 + 5 Idarubicin and Cytarabine Chemotherapy Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    October 20, 2025 (Anticipated)
    Study Completion Date
    October 20, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital of Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Reduced intensive 3 + 5 idarubicin and cytarabine chemotherapy plus venetoclax as first-line treatment for adults with acute myeloid leukaemia and high-risk myelodysplastic syndrome
    Detailed Description
    Multiple clinical trials about chemotherapy plus venetoclax in primary diagnosed AML or relapsed/refractly AML were ongoing to attempt the facility of the combination. Zu et al demostrated that full dose of 3 + 7 daunorubicin and cytarabine chemotherapy plus 8 days escalated venetoclax acheived 91% of CR/CRi with 97% 1-year overall survival and 72% 1-year event-free survival. In this trial , we try to reduced the intensive of 3 + 5 idarubicin and cytarabine chemotherapy, but prolong venetoclax to two weeks in the induction therapy in adults AML/MDS. We expect to increase the induced remission rate by extending the dosage of targeted drug venetoclax, and minimize the side effects by reducing the dose of 3 + 7 induction chemotherapy, so as to achieve the goal of high efficiency and low toxicity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myeloid Leukemia, Myelodysplastic Syndromes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Experimental
    Arm Description
    Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy
    Intervention Type
    Drug
    Intervention Name(s)
    idarubicin
    Other Intervention Name(s)
    Idamycin, Demethoxydaunorubicin
    Intervention Description
    Idarubicin 6mg/m2 d5-7
    Intervention Type
    Drug
    Intervention Name(s)
    Cytarabine
    Other Intervention Name(s)
    Cytosar, Cytosine arabinoside
    Intervention Description
    Cytarabine 60mg/m2 d5-9
    Primary Outcome Measure Information:
    Title
    CR
    Description
    assessment of the composite complete remission rate (CR=CR+CRi)
    Time Frame
    Week 6
    Secondary Outcome Measure Information:
    Title
    MRD
    Description
    assessment of bone marrow measurable residual disease by flow cytometry
    Time Frame
    Week 6
    Title
    EFS
    Description
    Evaluate the event-free survival
    Time Frame
    2 years
    Title
    OS
    Description
    Evaluated the overall survival
    Time Frame
    2 years
    Title
    adverse events
    Description
    Monitor of adverse events
    Time Frame
    at any time

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged 18-60 years had a confirmed diagnosis of previously untreated de novo acute myeloid leukaemia or high risk myelodysplastic syndrome by bone marrow examination according to the criteria presented by WHO. Eastern Cooperative Oncology Group performance status of 0-2. adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography. Exclusion Criteria: younger than 18 years old, or older than 60 years old. Diagnosed as acute promyelocytic leukaemia. Pretreated with anthracycline. CNS involvement. Positive for HIV, hepatitis B virus, or hepatitis C virus. New York Heart Association cardiovascular disability status higher than grade 2 (grade 2 is defined as cardiac disorder that is asymptomatic at rest, but ordinary physical activity might result in fatigue, palpitations, dyspnoea, or angina), chronic respiratory diseases requiring continuous supplementary oxygen, inability to take oral medication or malabsorption syndrome Uncontrollable systemic infection (viral, bacterial, or fungal), Inability to sign the informed consent form.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Weiyan Zheng, MD
    Phone
    86-13857187088
    Email
    zhengwy2015@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and Myelodysplastic Syndrome

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