NCT07023588

Brief Summary

A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
37mo left

Started Jun 2025

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 Progress24%
Jun 2025May 2029

Study Start

First participant enrolled

June 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

3.9 years

First QC Date

June 8, 2025

Last Update Submit

August 5, 2025

Conditions

Acute Myeloid Leukemia (AML)

Outcome Measures

Primary Outcomes (1)

  • Modified Composite Complete Response Rate（mCRc）

    Complete Response（CR） + Complete Response with Incomplete Hematologic Recovery（CRi）+Morphologic Leukemia Free State（MLFS）

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Overall Survival (OS)

    From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.

  • MRD Negative Conversion Rate

    Through study completion, an average of 1 year

  • Relapse-Free Survival(RFS)

    From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.

Study Arms (2)

venetoclax，8-14d

EXPERIMENTAL
Drug: Venetoclax

Control group

NO INTERVENTION

Interventions

VenetoclaxDRUG

Patients identified with a suboptimal response to chemotherapy based on minimal residual disease (MRD) levels in peripheral blood on Day 6 will initiate venetoclax therapy added on Day 8, administered for 7 days.

venetoclax，8-14d

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed AML patients confirmed by bone marrow morphology and immunophenotyping.
  • Complete MICM (Morphology, Immunophenotyping, Cytogenetics, Molecular genetics) work-up.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Day 6 Peripheral Blood Blast Percentage (D6PBBP) ≥ 1%.
  • Renal function with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured by 24-hour urine collection).
  • Liver function with Aspartate Aminotransferase (AST) ≤ 2.5 × ULN\*; Alanine Aminotransferase (ALT) ≤ 2.5 × ULN\*; Total bilirubin ≤ 1.5 × ULN\* (\*Unless considered due to leukemia infiltration).
  • Patients deemed suitable to receive DA/IA therapy by the investigator.
  • Signed informed consent form. -

You may not qualify if:

  • Acute promyelocytic leukemia (APL).
  • Mixed phenotype acute leukemia (MPAL).
  • AML patients with known central nervous system (CNS) involvement.
  • Presence of extramedullary disease (EMD).
  • Severe cardiac disease, including congestive heart failure, myocardial infarction, or cardiac dysfunction.
  • Concurrent active malignancy of other organ systems (patients with a history of cured malignancy may be eligible).
  • Active tuberculosis or HIV-positive patients.
  • Concurrent other hematological disorders.
  • Pregnant or lactating women.
  • Inability to comprehend or comply with the study protocol.
  • Hypersensitivity to any component of the drugs involved in the protocol.
  • Inability to take oral medication or patients with malabsorption syndrome.
  • Uncontrolled systemic infection.
  • Prior venetoclax treatment and/or current participation in any other study involving investigational agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Yehui Tan

CONTACT

8615948027438yhtan@jlu.edu.cn

Yuying Li

CONTACT

8613944135650lyying1001@jlu.edu.cn

Study Design

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

Study Record Dates

First Submitted

June 8, 2025

First Posted

June 17, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations

CN(1)