NCT07537257

Brief Summary

This study intends to use a randomized controlled design to compare the MRD-negativw rate and related efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) versus IDAC in the consolidation treatment of patients with AML after remission, providing high-quality evidence-based medical evidence for optimizing post-remission consolidation therapy for AML and improving patients' prognosis.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for phase_2

Timeline
36mo left

Started Apr 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress3%
Apr 2026Apr 2029

Study Start

First participant enrolled

April 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 3, 2026

Last Update Submit

April 12, 2026

Conditions

AML (Acute Myelogenous Leukemia)

Keywords

Acute myeloid leukemiaVenetoclaxCytarabineConsolidationMeasurable residual disease

Outcome Measures

Primary Outcomes (1)

  • Rate of Measurable residual disease (MRD) negative

    MRD is monitored using flow cytometric analysis with a positive MRD threshold of 0.1%.

    At the end of cycle 2 (28 days for a cycle)

Secondary Outcomes (5)

  • Cumulative Incidence of Recurrence (CIR)

    2 years

  • Overall survival (OS)

    2 years

  • Disease Free Survival (DFS)

    2 years

  • Aderse events

    At the end of cycle 2 (28 days for a cycle)

  • The rate of being bridged to allogeneic hematopoietic stem cell transplantation

    2 years

Study Arms (2)

VEN+IDAC

EXPERIMENTAL

Venetoclax 400mg per day from day 1 to day 7; cytarabine 1.5g/m\^2 q12h from day 1 to day 3.

Drug: VentoclaxDrug: Cytarabine

IDAC

ACTIVE COMPARATOR

Cytarabine 1.5g/m\^2 q12h from day 1 to day 3

Drug: Cytarabine

Interventions

VentoclaxDRUG

Venetoclax 400mg per day from day 1 to day 7

VEN+IDAC
CytarabineDRUG

Cytarabine 1.5g/m\^2 q12h from day 1 to day 3.

IDACVEN+IDAC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years, any gender;
  • Meet the WHO 2022 diagnostic criteria for acute myeloid leukemia (AML), and achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after induction therapy. CR is defined as bone marrow blasts ≤5%, absolute neutrophil count ≥1.0×10⁹/L, and platelets ≥100×10⁹/L; CRi is defined as bone marrow blasts ≤5%, absolute neutrophil count ≥0.5×10⁹/L, and platelets ≥50×10⁹/L;
  • Baseline MRD testing (using multiparameter flow cytometry, MFC) must be completed at enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
  • Major organ function is basically normal and meets the following requirements: ① Liver function: total bilirubin ≤1.5×ULN (except patients with liver metastasis or Gilbert's syndrome), ALT and AST ≤2.5×ULN; ② Kidney function: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 ml/min; ③ Cardiac function: left ventricular ejection fraction (LVEF) ≥50%;
  • The patient or their legal representative signs a written informed consent form, agrees to comply with the study protocol, and completes the specified follow-up procedures.

You may not qualify if:

  • Presence of other active malignant tumors (excluding indolent tumors that have been cured, such as basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • Central nervous system leukemia;
  • Existence of uncontrolled severe infection (such as sepsis, fungal pneumonia, active tuberculosis, etc.);
  • History of severe heart disease, including but not limited to: severe arrhythmias (such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate, etc.), history of myocardial infarction (within the past 6 months), severe heart failure (NYHA functional class ≥3), etc.;
  • Women who are pregnant or breastfeeding; women planning pregnancy or men of reproductive potential who have not used effective contraception during the study and within 6 months after treatment;
  • Known allergy to venetoclax, cytarabine, or other components of the combination regimen in the study;
  • Having mental illness (such as schizophrenia, major depressive disorder, etc.) or cognitive dysfunction that prevents cooperation with study follow-up and treatment;
  • Active hepatitis B virus infection (HBV DNA positive), active hepatitis C virus infection (HCV RNA positive), or human immunodeficiency virus (HIV) infection;
  • Undergoing major surgery, radiation therapy, other chemotherapy drugs, or investigational drug treatments within 3 weeks prior to study drug treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteNeoplasm, Residual

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 17, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2029

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)