Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS

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

Study Details

Study Description

Brief Summary

To explore the efficacy and safety of prolonged low-dose decitabine (10 days of 6mg/m2) plus venetoclax (3 weeks/cycle) regimen in primary diagnosed elderly or frail AML/ high-risk MDS.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are hematological malignancies. Some patients are over 65 years old, have poor response to traditional chemotherapy, and rarely have the opportunity to receive allogeneic hematopoietic stem cell transplantation, resulting in poor prognosis and short survival.

In recent years, with the advent of molecular targeted drugs Bcl-2 inhibitors, the treatment of elderly AML/ high-risk MDS has achieved breakthrough progress. In particular, the combination of demethylated drugs (decitabine/azacidacidin) and Bcl-2 inhibitors of chemotherapy-free regimen has been recommended by NCCN as the first-line treatment for elderly and frail patients.

However, how to achieve the optimal combination of decitabine and Bcl-2 inhibitors is an urgent problem to be solved.

Our previous pilot trial showed that prolonged low-dose decitabine combined with venetoclax (Bcl-2 inhibitor) resulted in higher complete remission rate, longer disease-free survival, and lower treatment-related risks.

The purpose of this study was to expand the multi-center sample to explore the efficacy and safety of prolonged low-dose decitabine plus venetoclax regimen in primary diagnosed elderly or frail AML/ high-risk MDS.

Study Design

Study Type:
Anticipated Enrollment :
120 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Multi-center Prospective Single Arm Clinical Study of Prolonged Ultra Low-dose Decitabine Combined With Venetoclax (Bcl-2 Inhibitor) as First Line Treatment for Elderly Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes
Anticipated Study Start Date :
Sep 27, 2023
Anticipated Primary Completion Date :
Sep 27, 2025
Anticipated Study Completion Date :
Sep 27, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment group

Acute Myeloid Leukemia Myelodysplastic Syndrome

Drug: Decitabine for Injection
6mg/m2, ivgtt qd d1-10
Other Names:
  • Dacogen
  • 5-Aza-29-deoxycytidine
    100mg p.o.d1, 200mg p.o.d2, 400mg p.o.d3-21,adjust by blood concentration
    Other Names:
  • Outcome Measures

    Primary Outcome Measures

    1. Complete response rate(CR+CRi) [at Week 8]

      Assessment of CR(CR=CR+CRi) at Week 8

    Secondary Outcome Measures

    1. MRD [at Week 8]

      Assessment of minimal residual disease (MRD) at Week 8

    2. EFS [up to 2 years after induction therpy]

      Evaluation of Event-free survival (EFS)

    3. OS [up to 2 years after induction therpy]

      Evaluation of overall survival (OS)

    Eligibility Criteria


    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    1. Patients must be diagnosed with acute myeloid leukemia (non-acute promyelocytic leukemia)/high-risk myelodysplastic syndrome before admission.

    Diagnostic criteria refer to 2016 WHO classification.

    1. Age 60 or older.

    2. The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1).

    3. Creatinine clearance ≥30 mL/min(as assessed by the Cockcrod-Gault formula [Cockcroft et al 1976] [13] or the estimated glomerular filtration rate [eGFR] from the Kidney Drink adjustment formula .

    4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN.

    5. Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50% (AHA 2016).

    6. Life expectancy >8 weeks.

    7. Sign the informed consent voluntarily, and understand and comply with the requirements of the study.

    Exclusion Criteria:
    1. Age <60 years old.

    2. Treated patients who had received various chemotherapy regiments.

    3. Present clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale (see Appendix 2), or history of myocardial infarction in the 6 months prior to screening.

    4. Other serious diseases that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes).

    5. Those who cannot understand and follow the research plan or sign the informed consent.

    Contacts and Locations


    Site City State Country Postal Code
    1 The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang China 310003

    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:
    • IIT202300032C
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 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 21, 2023