Myelodysplastic Syndromes Clinical Trial
Official title:
Prospective Pilot Study of the Clinical Efficacy and Safety of the Method for Preventing a Graft-versus-host Disease Through the Agency of Using the Combination of Post-transplantation Cyclophosphamide With Abatacept, Vedolizumab and Calcineurin Inhibitor at Children and Young Adults With Hemoblastosis After Hematopoietic Stem Cell Transplantation From an Unrelated or Haploidentic Donor
GVHD prevention using a combination of post-transplantation cyclophosphamide in combination with abatacept, vedolizumab and calcineurin inhibitor in children and young adults with hematoloblastosis after myeloablative conditioning regimen with treosulfan/TBI, cyclophosphamide/etoposide, fludarabine after HSCT from matched unrelated and haploidentical donors
Status | Active, not recruiting |
Enrollment | 56 |
Est. completion date | October 16, 2026 |
Est. primary completion date | August 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 21 Years |
Eligibility | Inclusion Criteria: 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% - 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology | Moscow | Samory-Mashela,1 |
Lead Sponsor | Collaborator |
---|---|
Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimate the probability of developing acute GVHD stage II-IV after HSCT | evaluation period is 120 days after HSCT | ||
Primary | severe (3-5 degrees) side effects of conditioning | evaluation period is 30 days after HSCT | ||
Secondary | event free survival | up to 100 days after HSCT | ||
Secondary | transplantation-associated mortality | up to 100 days after HSCT | ||
Secondary | relapse free survival | up to 100 days after HSCT | ||
Secondary | pathogen-specific immunoreconstitution | after HSCT up to 180 days | ||
Secondary | reactivation of CMV | after HSCT up to 180 days |
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