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Clinical Trial NCT07047183 for Myelodysplastic Neoplasms, Transplantation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes Phase 2 46

Recruiting
Clinical Trial NCT07047183 is designed to study Treatment for Myelodysplastic Neoplasms, Transplantation. It is a Phase 2 interventional study that is recruiting, having started on 1 July 2025, with plans to enroll 46 participants. Led by Yehui Tan, it is expected to complete by 30 June 2029. The latest data from ClinicalTrials.gov was last updated on 8 August 2025.
Brief Summary
A Single-Arm, Prospective Clinical Study of Venetoclax Combined with Azacitidine Followed by Bridging Transplantation in Patients with High-Risk Myelodysplastic Neoplasms with Increased Blasts 2 (MDS-IB2)
Detailed Description
This is a single-center, single-arm, prospective study investigating pre-transplant bridging therapy in patients aged ≥18 years with higher-risk MDS-IB2. The study plans to enroll 46 eligible patients. Participants will receive Venetoclax combined with Azacitidine, administered in 28-day cycles for 1 to 2 cycles. Treatment response will be assessed according to the IWG 2023 HR-MDS response criteria.Patients achieving...Show More
Official Title

A Single-Arm, Prospective Clinical Study of Venetoclax Combined With Azacitidine Followed by Bridging Transplantation in Patients With High-Risk Myelodysplastic Neoplasms With Increased Blasts 2 (MDS-IB2)

Conditions
Myelodysplastic NeoplasmsTransplantation
Other Study IDs
  • 2025-HS-061
NCT ID Number
NCT07047183
Start Date (Actual)
2025-07-01
Last Update Posted
2025-08-08
Completion Date (Estimated)
2029-06-30
Enrollment (Estimated)
46
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalvenetoclax + Azacitidine
VEN (Venetoclax)
Enrolled patients will receive: Venetoclax: 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3-14. Azacitidine: 75 mg/m² on Days 1-7. Cycle duration: 28 days Total cycles: 1 to 2 cycles
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
2-Year Relapse-Free Survival(2-RFS)
Defined as the time from enrollment in this study to the occurrence of relapse. For patients without relapse, the time is calculated until death from any cause or the time of the last follow-up
From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 24 months.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall Survival (OS)
Defined as the time from enrollment in this study to death from any cause. If the exact date of death is unknown, the time of death is defined as the last contact date. If the patient is still alive, the last observed time will be used, and the patient's OS will be considered for analysis.
From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
Cumulative Relapse Rate (CIR)
Defined as the proportion of patients who experience disease relapse from the time of enrollment in this study.
rom date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 24 months.
Composite Complete Response Rate（mCRc）
Complete Remission (CR) or CR-equivalent+ CR with partial hematologic recovery (CRL) + CR with limited hematologic recovery (CRh)
Through study completion, an average of 1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  1. Newly diagnosed MDS confirmed by morphological and immunophenotypic analysis of bone marrow；

  2. Age ≥18 years, any gender；

  3. Bone marrow blasts ≥10%；

  4. IPSS-R score >4.5；

  5. ECOG performance status 0-2；

  6. Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT)；

  7. Adequate major organ function：

    • Cardiac: LVEF ≥50%
    • Hepatic: Bilirubin ≤1.5×ULN
    • AST/ALT ≤2.5×ULN
    • Renal: Creatinine clearance ≥60 mL/min；

  8. Written informed consent provided by the patient or legally authorized representative.

  1. Extramedullary disease involvement；
  2. Hypersensitivity to any study drugs；
  3. Clinically significant hepatic/renal dysfunction exceeding inclusion thresholds；
  4. Severe cardiac disease, including congestive heart failure, myocardial infarction, and cardiac insufficiency;
  5. Concurrent malignant tumors of other organs, which can be enrolled if previously cured;
  6. Active tuberculosis or HIV infection;
  7. Concomitant hematologic disorders;
  8. Pregnancy or lactation;
  9. Inability to comply with protocol requirements;
  10. Concurrently participating in other clinical studies.
Yehui Tan logoYehui Tan
Study Responsible Party
Yehui Tan, Sponsor-Investigator, Professor, The First Hospital of Jilin University
Study Central Contact
Contact: Yehui Tan, 8615948027438, [email protected]
Contact: Yuying Li, 8613944135650, [email protected]
1 Study Locations in 1 Countries

Jilin

The First Hospital of Jilin University, Changchun, Jilin, 130000, China
Recruiting