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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
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.
RM Gorbacheva Research Institute
Saint Petersburg, Russia
Relapse - free survival
Estimate time to morphological relapse by Kaplan Mayer
Time frame: 24 months
Overall survival analysis
Estimate time to death by Kaplan Mayer
Time frame: 24 months
Relapse rate analysis
Cumulative incidence of patients with relapse by Gray's test
Time frame: 24 months
Non-relapse mortality analysis
Cumulative incidence of patients with mortality without hematological relapse of malignancy
Time frame: 24 months
Incidence of acute GVHD grade II-IV
Cumulative incidence of patients with acute GVHD II-IV grade by Gray's test
Time frame: 125 days
Incidence of moderate and severe chronic GVHD
Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria by Gray's test
Time frame: 24 months
Incidence of achievement MRD negative status
Cumulative incidence of patients with MRD positive status, who had responds to therapy Gray's test
Time frame: 24 months
Relapse - free survival
Estimate time to appearing of MRD or morphological relapse by Kaplan Mayer
Time frame: 24 months
Graft - versus -host-disease free/relapse free survival
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
Time frame: 24 months
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