Clinical trial · Interventional
Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes
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)
NCT07047183CI-TRIAL-00093370recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Neoplasms | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VEN (Venetoclax) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- venetoclax + Azacitidine
- interventionNames
- Drug: VEN (Venetoclax)
Primary outcomes (1)
- measure
- 2-Year Relapse-Free Survival(2-RFS)
- timeFrame
- From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 24 months.
- description
- 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
Secondary outcomes (3)
- measure
- Overall Survival (OS)
- timeFrame
- From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.