Actively Recruiting
Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT for 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
On this page
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 1/2 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 treatment's 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
- The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- The patient should be diagnosed with higher risk MDS according to the standard criteria of the World Health Organization (WHO).
You will not qualify if you...
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 14 days
Participants receive Venetoclax and Azacytidine as a conditioning regimen before transplantation.
Daily medication and injections for 14 days
Duration - Approximately 1 day for stem cell infusion
Participants undergo allogeneic hematopoietic stem cell transplantation (Allo-HSCT) with donor stem cells infused on day 9 of the conditioning regimen.
1 infusion visit
Duration - Up to 3 years
Participants are monitored for overall survival, progression-free survival, and incidence of graft-versus-host disease for up to 3 years after transplantation.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Navy General Hospital
Beijing, Beijing Municipality, China, 100048
Actively Recruiting
Research Team
L
Liren Qian, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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