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Phase 2
Age: 70Years +
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ID06471946

Safety and Effectiveness of Venetoclax Plus Azacytidine Conditioning and Allo-HSCT in Elderly Patients with Higher-risk Myelodysplastic Syndromes

Led by Navy General Hospital, Beijing · Updated on 2024-10-01

54

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new treatment called Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT for elderly patients with higher-risk Myelodysplastic Syndromes MDS. This phase 12 trial focuses on patients aged 70 and older and aims to improve outcomes after transplantation by examining overall survival and other important health measures. The study is led by Navy General Hospital in Beijing and will follow patients for up to three years after treatment. Participants receive a combination of Venetoclax and Azacytidine as a conditioning regimen before receiving donor stem cells through allogeneic hematopoietic stem cell transplantation Allo-HSCT. Venetoclax is given orally in increasing doses over 14 days, while Azacytidine is injected daily for seven days. Donor stem cells are infused on day 9. This treatment approach aims to prepare the body for transplantation and support recovery. During the study, participants will be closely monitored for overall survival, progression-free survival, and the occurrence of acute and chronic graft-versus-host disease GVHD. Researchers will also track non-relapse mortality and GVHD-free relapse-free survival over three years following transplant. Regular assessments and follow-up visits will help evaluate the treatments safety and impact on patients health and quality of life throughout the study period.

CONDITIONS

Brief Title

VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS

Research Team

L

Liren Qian, PhD

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