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

First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Not yet recruiting ID

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Anticipated Enrollment :
60 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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
Anticipated Study Start Date :
Oct 20, 2023
Anticipated Primary Completion Date :
Oct 20, 2025
Anticipated Study Completion Date :
Oct 20, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment group

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

Drug: idarubicin
Idarubicin 6mg/m2 d5-7
Other Names:
  • Idamycin
  • Demethoxydaunorubicin
  • Drug: Cytarabine
    Cytarabine 60mg/m2 d5-9
    Other Names:
  • Cytosar
  • Cytosine arabinoside
  • Outcome Measures

    Primary Outcome Measures

    1. CR [Week 6]

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

    Secondary Outcome Measures

    1. MRD [Week 6]

      assessment of bone marrow measurable residual disease by flow cytometry

    2. EFS [2 years]

      Evaluate the event-free survival

    3. OS [2 years]

      Evaluated the overall survival

    4. adverse events [at any time]

      Monitor of adverse events

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    1. aged 18-60 years

    2. 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.

    3. Eastern Cooperative Oncology Group performance status of 0-2.

    4. adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.

    Exclusion Criteria:
    1. younger than 18 years old, or older than 60 years old.

    2. Diagnosed as acute promyelocytic leukaemia.

    3. Pretreated with anthracycline.

    4. CNS involvement.

    5. Positive for HIV, hepatitis B virus, or hepatitis C virus.

    6. 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

    7. Uncontrollable systemic infection (viral, bacterial, or fungal),

    8. Inability to sign the informed consent form.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Weiyan Zheng, Clinical Professor, First Affiliated Hospital of Zhejiang University Identifier:
    Other Study ID Numbers:
    • 20230413IAVEN
    First Posted:
    Sep 22, 2023
    Last Update Posted:
    Sep 22, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2023