NCT06046313

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
6mo left

Started Oct 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2023Oct 2026

First Submitted

Initial submission to the registry

April 13, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

October 19, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2026

Expected
Last Updated

March 5, 2024

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

April 13, 2023

Last Update Submit

March 2, 2024

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

  • Complete response rate(CR+CRi)

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

    at Week 8

Secondary Outcomes (3)

  • MRD

    at Week 8

  • EFS

    up to 2 years after induction therpy

  • OS

    up to 2 years after induction therpy

Study Arms (1)

treatment group

EXPERIMENTAL

Acute Myeloid Leukemia Myelodysplastic Syndrome

Drug: Decitabine for InjectionDrug: VENCLYXTO

Interventions

Decitabine for InjectionDRUG

6mg/m2, ivgtt qd d1-10

Also known as: Dacogen, 5-Aza-29-deoxycytidine
treatment group
VENCLYXTODRUG

100mg p.o.d1, 200mg p.o.d2, 400mg p.o.d3-21,adjust by blood concentration

Also known as: VENLEXTA
treatment group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

DecitabineInjections

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Weiyan Zheng, MD

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiyan Zheng, MD

CONTACT

86-13857187088zhengwy2015@163.com

Xuepin Luo, MD

CONTACT

86-15167157190luoxp1603@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 13, 2023

First Posted

September 21, 2023

Study Start

October 19, 2023

Primary Completion

October 19, 2025

Study Completion (Estimated)

October 19, 2026

Last Updated

March 5, 2024

Record last verified: 2023-04

Locations

CN(1)