drugset / Trial / NCT05009719

Risk-adapted Donor Lymphocyte Infusion After Allo-HSCT in Children With Hematologic Malignancy

NCT05009719

Phase 1/2 Completed 50 enrolled St. Petersburg State Pavlov Medical University
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Allo-hsct is potentially curative method of treatment for children and adolescent with hematologic malignancy. However, relapses of disease after allo-hsct occur up to 50% of patients and constitute the main cause of mortality after HSCT. Donor lymphocytes infusion (DLI) is a form of immunotherapy based on developement of reaction "graft versus from leukemia". This study evaluates the safety and efficacy of risk-adapted srtategy of DLI for prophylaxis and prevention posttransplant relapses in children and adolescent with hematologic malignancy.

Timeline

Start
2021-04-01
Primary completion
2023-04-01
Completion
2024-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject donor lymphocytes Cell therapy 100000 cells/kg Intravenous
Subject donor lymphocytes Cell therapy 1e+06 cells/kg Intravenous
Subject donor lymphocytes Cell therapy 1e+08 cells/kg Intravenous