Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 12, 2024

Primary Completion Date

November 12, 2027

Study Completion Date

November 12, 2028

Conditions
Myelodysplastic Syndromes, Adult
Interventions
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"

Trial Locations (1)

200080

RECRUITING

Shanghai General Hospital, Shanghai

All Listed Sponsors
lead

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER