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
Study ID
NCT06475820
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Day - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    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.

Study Details

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

Key Dates

Start date
Dec 1, 2023
Status verified
Apr 2024
Primary completion
Jul 1, 2024
Completion
Apr 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib and Cyclophosphamide
    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.

Primary Outcome Measure

Estimate the probability of developing acute GVHD stage II-IV after HSCT [ Time Frame: 100 days after HSCT ]

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