search
Back to results

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

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndromes

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Decitabine for Injection
VENCLYXTO
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

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Age 60 or older. The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1). 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 . Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN. Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50% (AHA 2016). Life expectancy >8 weeks. Sign the informed consent voluntarily, and understand and comply with the requirements of the study. Exclusion Criteria: Age <60 years old. Treated patients who had received various chemotherapy regiments. 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. Other serious diseases that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes). Those who cannot understand and follow the research plan or sign the informed consent.

Sites / Locations

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

Acute Myeloid Leukemia Myelodysplastic Syndrome

Outcomes

Primary Outcome Measures

Complete response rate(CR+CRi)
Assessment of CR(CR=CR+CRi) at Week 8

Secondary Outcome Measures

MRD
Assessment of minimal residual disease (MRD) at Week 8
EFS
Evaluation of Event-free survival (EFS)
OS
Evaluation of overall survival (OS)

Full Information

First Posted
April 13, 2023
Last Updated
September 18, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT06046313
Brief Title
Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 27, 2023 (Anticipated)
Primary Completion Date
September 27, 2025 (Anticipated)
Study Completion Date
September 27, 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
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.
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.

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
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
Acute Myeloid Leukemia Myelodysplastic Syndrome
Intervention Type
Drug
Intervention Name(s)
Decitabine for Injection
Other Intervention Name(s)
Dacogen, 5-Aza-29-deoxycytidine
Intervention Description
6mg/m2, ivgtt qd d1-10
Intervention Type
Drug
Intervention Name(s)
VENCLYXTO
Other Intervention Name(s)
VENLEXTA
Intervention Description
100mg p.o.d1, 200mg p.o.d2, 400mg p.o.d3-21,adjust by blood concentration
Primary Outcome Measure Information:
Title
Complete response rate(CR+CRi)
Description
Assessment of CR(CR=CR+CRi) at Week 8
Time Frame
at Week 8
Secondary Outcome Measure Information:
Title
MRD
Description
Assessment of minimal residual disease (MRD) at Week 8
Time Frame
at Week 8
Title
EFS
Description
Evaluation of Event-free survival (EFS)
Time Frame
up to 2 years after induction therpy
Title
OS
Description
Evaluation of overall survival (OS)
Time Frame
up to 2 years after induction therpy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Age 60 or older. The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1). 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 . Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN. Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50% (AHA 2016). Life expectancy >8 weeks. Sign the informed consent voluntarily, and understand and comply with the requirements of the study. Exclusion Criteria: Age <60 years old. Treated patients who had received various chemotherapy regiments. 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. Other serious diseases that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes). Those who cannot understand and follow the research plan or sign the informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiyan Zheng, MD
Phone
86-13857187088
Email
zhengwy2015@163.com
Facility Information:
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiyan Zheng, MD
Phone
86-13857187088
Email
zhengwy2015@163.com
First Name & Middle Initial & Last Name & Degree
Weiyan Zheng, MD
First Name & Middle Initial & Last Name & Degree
Xuepin Luo, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs