drugset / Trial / NCT06490562

Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI

NCT06490562

RandomizedParallel-groupOpen-labelPrevention

Summary

Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.

Timeline

Start
2024-07
Primary completion
2028-05
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CSA Unknown 25 mg Oral
Subject Cyclophosphamide Other / unclassified 30 mg/kg
Subject Tacrolimus Small molecule 0.25 mg Oral