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NCT07047183RecruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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)

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
46 (estimated)
First submitted
24 Jun 2025
Start date
1 Jul 2025
Primary completion date
30 Jun 2029
Lead sponsor
Yehui Tan
NCT number
NCT07047183

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 46
  • From 1 Jul 2025 to the primary completion date, 30 Jun 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent malignant tumors of other organs, which can be enrolled if previously cured;
  • Concomitant hematologic disorders;

Other illness

  • Extramedullary disease involvement;
  • Hypersensitivity to any study drugs;
  • Severe cardiac disease, including congestive heart failure, myocardial infarction, and cardiac insufficiency;
  • Active tuberculosis or HIV infection;

Other

  • Clinically significant hepatic/renal dysfunction exceeding inclusion thresholds;
  • Pregnancy or lactation;
  • Inability to comply with protocol requirements;
  • Concurrently participating in other clinical studies.

Who the study is looking for

  • Newly diagnosed MDS confirmed by morphological and immunophenotypic analysis of bone marrow;
  • Age ≥18 years, any gender;
  • Bone marrow blasts ≥10%;
  • IPSS-R score \>4.5;
  • ECOG performance status 0-2;
  • Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT);
  • Adequate major organ function:
    • Cardiac: LVEF ≥50%
    • Hepatic: Bilirubin ≤1.5×ULN
    • AST/ALT ≤2.5×ULN
    • Renal: Creatinine clearance ≥60 mL/min;
  • Written informed consent provided by the patient or legally authorized representative.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.