Preventing of GVHD with Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Ruxolitinib At Children and Young Adults with Hemoblastosis

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 10, 2024

Primary Completion Date

July 10, 2026

Study Completion Date

October 10, 2026

Conditions
Biphenotypic Acute LeukemiaAcute Lymphoblastic LeukemiaMyeloblastic LeukemiaBilinear LeukemiaMalignant Lymphoma, Non-HodgkinMyelodysplastic Syndrome
Interventions
DRUG

Conditioning regimen: Treosulfan 42 g/m2/course or total body irradiation 12 Gray/course, Etoposide 60 mg/kg , Fludarabine 150

The most significant adverse events limiting the use of HSCT from an unrelated donor are graft-versus-host disease (GVHD) and prolonged immunodeficiency associated with the development of severe infectious complications. The use of post-transplant cyclophosphamide for the prevention of GVHD during allogeneic HSCT from unrelated and haploidentical donors has reduced the incidence of acute clinically significant GVHD in children to 25%, chronic GVHD to 12-30%, but the issue of GVHD control still remains extremely relevant. Emerging data on the use of abatacept, a selective blocker of the costimulatory signal from an antigen-presenting cell, in the prevention of intestinal GVHD and data on the effectiveness of Janus-kinase type 1/2 inhibitors (JAK-1/2) in the treatment and prevention of acute GVHD allow us to justify the use of these drugs in combination with post-transplant cyclophosphamide as a promising pharmacological platform for the prevention of GVHD.

Trial Locations (1)

117198

RECRUITING

National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow

All Listed Sponsors
lead

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

OTHER