Venetoclax & Azacitidine Plus Transplantation in High-Risk Myelodysplastic Neoplasms with Increased Blasts 2 (MDS-IB2)
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.
VEN (Venetoclax)
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.46 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
The First Hospital of Jilin University
Changchun, ChinaOpen The First Hospital of Jilin University in Google Maps