RM Gorbacheva Research Institute
Saint Petersburg, 197022, Russia
NCT Number: NCT05009719
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.
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Notify Me4 month–18 year
All sexes
Interventional
Phase 1 / Phase 2
Saint Petersburg, 197022, Russia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 24 months
Estimate time to morphological relapse by Kaplan Mayer
Time frame: 24 months
Estimate time to death by Kaplan Mayer
Time frame: 24 months
Cumulative incidence of patients with relapse by Gray's test
Time frame: 24 months
Cumulative incidence of patients with mortality without hematological relapse of malignancy
Time frame: 125 days
Cumulative incidence of patients with acute GVHD II-IV grade by Gray's test
Time frame: 24 months
Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria by Gray's test
Time frame: 24 months
Cumulative incidence of patients with MRD positive status, who had responds to therapy Gray's test
Time frame: 24 months
Estimate time to appearing of MRD or morphological relapse by Kaplan Mayer
Time frame: 24 months
Estimate time to date of III-IV acute GVHD (aGVHD), chronic GVHD (cGVHD) requiring systemic immunosuppressive treatment, disease relapse or death from any other cause by Kaplan Mayer
St. Petersburg State Pavlov Medical University
Other
Study of the Efficacy and Safety of Risk-adapted Donor Lymphocyte Infusions for the Prophylaxis and Prevention of Relapses After Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescent With Hematologic Malignancy
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