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

Sponsors and collaborators

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Lead sponsor

Source ClinicalTrials.gov