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Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis
Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Summary
GVHD prevention using a combination of post-transplantation cyclophosphamide in combination with abatacept, vedolizumab and and Baricitinib in children and young adults with hematoloblastosis after myeloablative conditioning regimen with treosulfan/TBI, cyclophosphamide/etoposide, fludarabine after HSCT from matched unrelated and haploidentical donors
Official title: Prospective Pilot Study of the Clinical Efficacy and Safety of the Method for Preventing a Graft-versus-host Disease Through the Agency of Using the Combination of Post-transplantation Cyclophosphamide With Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis After Hematopoietic Stem Cell Transplantation From an Unrelated or Haploidentic Donor
Key Details
Gender
All
Age Range
1 Day - 21 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-12-01
Completion Date
2027-04-01
Last Updated
2024-08-23
Healthy Volunteers
No
Conditions
Interventions
Baricitinib
GVHD prevention using a combination of post-transplantation cyclophosphamide Prevention of GVHD: Cyclophosphamide 80 mg/kg/course on the days +3, +4 Abatacept 10 mg/kg/day on the days +5, +14, +28, +60, +90 Vedolizumab 10 mg/kg/day, max. 300 mg on the days 0, +14, +28, +60 Baricitinib 4 mg/day per os (patient age \> 9 years), 2 mg/day (patient age \< 9 years), from day -3 to day +90 (after HSCT), orally, once a day.
Locations (1)
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow, Samory-Mashela,1, Russia