Actively Recruiting
Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification: A Single-Arm, Prospective, Single-Center Clinical Study
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-11-26
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a prophylactic intervention to prevent relapse and improve survival rates after allogeneic transplantation in adult patients with very high-risk myelodysplastic syndromes (MDS) based on IPSS-M stratification. This Phase 2 study aims to assess relapse-free survival at 1 and 2 years post-transplantation by comparing clinical data with historical outcomes. The focus is on reducing disease progression or death following transplantation in this high-risk group. The intervention involves a combination of drugs and cellular therapy. The preferred regimen includes subcutaneous azacitidine injections for 5 consecutive days every 28 days, combined with oral BCL2 inhibitor (venetoclax) for one week per cycle. For patients with specific mutations or resistance to venetoclax, azacitidine plus decitabine and donor lymphocyte infusion (DLI) starting 3 months after transplantation are used, with escalating doses of T lymphocytes. This single-arm, prospective study is conducted at a single center. Participants will be monitored for disease relapse and overall survival over 1 and 2 years. Evaluations include clinical assessments of disease progression, organ function tests, and performance status. Researchers will track relapse-free survival as the primary outcome and overall survival as a secondary outcome. The study runs from November 2024 to November 2028, with participants receiving ongoing follow-up to evaluate long-term outcomes and safety.
CONDITIONS
Brief Title
Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, inclusive, male or female
- Diagnosed with myelodysplastic syndromes (MDS) according to WHO criteria
- Classified as very high risk by IPSS-M scoring
- Suitable hematopoietic stem cell donor: related donors must be at least 5/10 HLA matched; unrelated donors must be at least 8/10 HLA matched
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of 2 or less
- ECOG performance status between 0 and 2
- Adequate liver, kidney, cardiac, and pulmonary functions as defined by study criteria
- Capable of understanding and willing to participate, with signed informed consent
You will not qualify if you...
- Failure to proceed with stem cell reinfusion after unsuccessful pre-transplant conditioning
- Previous hematopoietic stem cell transplantation (HSCT)
- ECOG performance status greater than 2
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of 3 or more
- Unstable systemic diseases including recent heart attack, stroke, congestive heart failure (NYHA class III or higher), or severe arrhythmias
- Severe liver, kidney, or metabolic diseases
- Pulmonary arterial hypertension
- Active, uncontrolled infections or persistent fever without clear cause
- Neurological conditions requiring Grade 2 or higher treatment, including epilepsy and severe brain trauma
- HIV infection
- Active hepatitis B or C requiring antiviral treatment
- Risk of hepatitis B reactivation without antiviral therapy
- Pregnant or breastfeeding women
- Men and women of childbearing potential unwilling to use contraception during and for 12 months after treatment
- Allergic to study drugs such as azacitidine, decitabine, or venetoclax
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.
1 visit (in-person)
Duration - Repeated 28-day cycles starting 3 months post-transplantation with dose escalations every 4 to 6 weeks
Participants receive prophylactic intervention post-allogeneic transplantation to prevent relapse. This includes subcutaneous azacitidine injections and oral BCL2 inhibitor or decitabine with donor lymphocyte infusion depending on individual conditions.
Visits aligned with each 28-day treatment cycle and additional visits for dose escalation assessments every 4 to 6 weeks
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China, 200080
Actively Recruiting
Research Team
X
Xianmin Song, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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