Recruiting

Venetoclax & Azacitidine Plus Transplantation in High-Risk Myelodysplastic Neoplasms with Increased Blasts 2 (MDS-IB2)

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Study Aim

This clinical trial is for adults with high-risk myelodysplastic neoplasms and increased blasts. It studies the use of Venetoclax and Azacitidine plus transplantation, aiming to improve 2-year relapse-free survival.

What is being tested

VEN (Venetoclax)

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorYehui Tan
Study ContactYehui TanMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on patients aged 18 and above who have high-risk myelodysplastic neoplasms with increased blasts, a condition where the blood cells do not mature properly. The main goal is to find out how effective a combination of two medications, Venetoclax and Azacitidine, is before patients undergo a stem cell transplant. By using these drugs together, researchers hope to improve patients' conditions enough to make the transplant more successful. This is important because finding a better way to prepare patients for transplantation could lead to better outcomes for those at high risk. Participants in the study receive Venetoclax and Azacitidine in 28-day treatment cycles, either once or twice, depending on their response to the first cycle. The progress is checked using specific criteria to see if the treatment is working. If a patient shows a very good response after the first cycle, they move directly to the transplant stage. If not, they receive a second cycle before potentially undergoing the stem cell transplant. If a transplant is not possible, patients receive standard care and are monitored. The study helps determine how well these treatments prepare patients for the next step in their care.

Official TitleA 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)
NCT07047183
Principal SponsorYehui Tan
Study ContactYehui TanMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The First Hospital of Jilin University

Changchun, ChinaOpen The First Hospital of Jilin University in Google Maps
Recruiting
One Study Center