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

RecruitingPhase 2, Phase 3Ages 1 Day - 21 YearsAllFederal Research Institute of Pediatric Hematolog…
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1\. Patients under the age of 21 years with following diseases: * acute lymphoblastic, * myeloblastic, * biphenotypic, * bilinear leukemia, * malignant lymphoma, * myelodysplastic syndrome, Exclusion Criteria: Age over 21 years * Patients with ALL outside clinical and hematological remission * Clinical status: * 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 * Liver function: total bilirubin, ALT, AST, ALP \> 2 norms * Lung function: lung capacity \<50%, for children who cannot carry out of respiratory function - oxygen saturation during pulse oximetry \<92% * Uncontrolled viral, fungal or bacterial infection. * Mental illness of the patient or caregivers, making it impossible to realize the essence of the study and compromising compliance with medical appointments and sanitary and hygienic regime 1 These patients may receive treatment according to the protocol, but the results will be evaluated separately
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What it tests

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

1 site
National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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