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

RECRUITINGPhase 2/3Sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Actively Recruiting
PhasePhase 2/3
SponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology
Started2024-07-10
Est. completion2026-07-10
Eligibility
Age1 Day – 21 Years
Healthy vol.Accepted

Summary

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

Age: 1 Day – 21 YearsHealthy volunteers accepted
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

Conditions7

Acute Lymphoblastic LeukemiaBilinear LeukemiaBiphenotypic Acute LeukemiaCancerMalignant Lymphoma, Non-HodgkinMyeloblastic LeukemiaMyelodysplastic Syndrome

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