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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06046313
Other study ID # IIT202300032C
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 19, 2023
Est. completion date October 19, 2026

Study information

Verified date April 2023
Source First Affiliated Hospital of Zhejiang University
Contact Weiyan Zheng, MD
Phone 86-13857187088
Email zhengwy2015@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 19, 2026
Est. primary completion date October 19, 2025
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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. 2. Age 60 or older. 3. The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1). 4. 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 . 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=3× upper limit of normal range (ULN), total bilirubin =2×ULN. 6. Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)=50% (AHA 2016). 7. Life expectancy >8 weeks. 8. 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.

Study Design


Intervention

Drug:
Decitabine for Injection
6mg/m2, ivgtt qd d1-10
VENCLYXTO
100mg p.o.d1, 200mg p.o.d2, 400mg p.o.d3-21,adjust by blood concentration

Locations

Country Name City State
China The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete response rate(CR+CRi) Assessment of CR(CR=CR+CRi) at Week 8 at Week 8
Secondary MRD Assessment of minimal residual disease (MRD) at Week 8 at Week 8
Secondary EFS Evaluation of Event-free survival (EFS) up to 2 years after induction therpy
Secondary OS Evaluation of overall survival (OS) up to 2 years after induction therpy
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