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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2021

Primary Completion Date

April 1, 2023

Study Completion Date

April 1, 2024

Conditions
Hematologic Malignancy
Interventions
BIOLOGICAL

Prophylactic Donor lymphocytes infusions

"Donor lymphocytes is taken by apheresis or dose of blood from allogeneic donor. After apheresis lymphocytes arel freezed for next using. DLI is transfused to patients IV using central venous access.~Donor lymphocytes infusion start from D+60 - D+100 and continue with escalating doses every 1.5-3 months during first year after HSCT up to appearance of GVHD or signs of disease. First dose is 1\*10\*6 CD3+/kg. Subsequent doses increases by 0.5 log for haploidentical and unrelated donor and 1 log for sibling donor up to 1\*10\*8 CD3+/kg."

BIOLOGICAL

Preventive Donor lymphocytes infusions

"Donor lymphocytes is taken by apheresis or dose of blood from allogeneic donor. After apheresis lymphocytes freeze for next using. DLI are transfused to patients IV using central venous access.~Donor lymphocytes infusion continue with escalating doses every 1.5-3 months up to achieving MRD negative status or appearance of GVHD or signs of active disease.~First dose is 1\*10\*6 CD3+/kg for patients without previous GVHD and 1\*10\*5 CD3+/kg for patients with previous GVHD. Subsequent doses increases by 0.5 log for haploidentical and unrelated donor and 1 log for sibling donor up to 1\*10\*8 CD3+/kg."

Trial Locations (1)

197022

RM Gorbacheva Research Institute, Saint Petersburg

All Listed Sponsors
lead

St. Petersburg State Pavlov Medical University

OTHER

NCT05009719 - Risk-adapted Donor Lymphocyte Infusion After Allo-HSCT in Children With Hematologic Malignancy | Biotech Hunter | Biotech Hunter