A Phase 2 interventional study of Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Myelodysplastic Syndromes, Adult, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Prevention
By collecting interventional clinical data to assess the survival and relapse conditions of patients post-transplantation and comparing them with historical data, the primary study endpoint is the 1-year and 2-year relapse-free survival (RFS) post-transplantation. This includes the time from the start of treatment until the documentation of disease progression (bone marrow smear blast cells > 5% or extramedullary relapse) or death due to any cause, whichever occurs first. This experiment aims to improve the post-transplant survival rates of MDS patients classified as very high risk under the IPSS-M stratification and to explore pathways to prevent relapse.
2,124 studies on the registry are indexed under Myelodysplastic Syndromes; 320 are open to participants now.
This study's planned enrollment of 40 is close to the median of 39 across 1,740 interventional studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation
1.1 AZA + BCL2 Inhibitor (Preferred Regimen) Subcutaneous injection of azacitidine at 32 mg/m² per day for 5 consecutive days, with a 28-day cycle; BCL2 inhibitor (VEN): 400 mg per day orally for one week (if combined with a CYP450 inhibitor, reduce to 100 mg per day). 1.2 AZA (DEC) + DLI For patients with TP53 mutations or those who do not respond to VEN, subcutaneous injection of azacitidine at 32 mg/m² per day for 5 consecutive days, with a 28-day cycle; decitabine at 5 mg/m² per day for 5 consecutive days, with a 28-day cycle (preferred for those with TP53 mutations). For patients without the option for DLI, regimen 1.1 is recommended. DLI: Begins 3 months post-transplantation, starting with a dose of 1×10\^5 CD3+ T lymphocytes for haploidentical transplants, with doses increasing every 4-6 weeks to 5×10\^5 CD3+ T lymphocytes, 1×10\^6 CD3+, and 5×10\^6 CD3+ T lymphocytes; for full-matched transplants, the starting dose is 5×10\^5 CD3+ T lymphocytes with dose escalations as above to 1×1
RFS:relapse-free survival
Time frame: 1 year
RFS:relapse- free survival
Time frame: 2 year
OS:overall survival
Time frame: 1 year
OS:overall survival
Time frame: 2 year
Plan to share: Undecided
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine