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

ConditionsBiphenotypic Acute Leukemia Acute Lymphoblastic Leukemia Myeloblastic Leukemia Bilinear Leukemia Malignant Lymphoma, Non-Hodgkin Myelodysplastic Syndrome

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age1-21

SponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology

About this trial

GVHD prevention using a combination of post-transplantation cyclophosphamide in combination with abatacept, vedolizumab and Ruxolitinib in children and young adults with hematoloblastosis after myeloablative conditioning regimen with treosulfan/TBI, etoposide, fludarabine after HSCT from matched unrelated and haploidentical donors

Eligibility criteria

Qualifiers

acute lymphoblastic,

myeloblastic,

biphenotypic,

bilinear leukemia,

Disqualifiers

Patients with ALL outside clinical and hematological remission

Lansky/Karnowski index <70% (supplement No.1)

Heart function: left ventricular ejection fraction <40% according to ultrasound of the heart1

Kidney function: clearance of endogenous creatinine < 70 ml / min

Trial design

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 1 treatment group

Locations

National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov117198, Moscow Russia

Sponsors and collaborators

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Lead sponsor

Source ClinicalTrials.gov