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ACTIVE NOT RECRUITING
NCT06475820
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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