Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis

Phase 2

Active, not recruiting

• Conditions: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Biphenotypic Acute Leukemia; Malignant Lymphoma; Myelodysplastic Syndromes

• Registration Number: NCT06475820
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br>following diseases:<br><br> - acute lymphoblastic,<br><br> - myeloblastic,<br><br> - biphenotypic,<br><br> - bilinear leukemia,<br><br> - malignant lymphoma,<br><br> - myelodysplastic syndrome, 2. Donors:<br><br> - voluntary fully HLA-matched unrelated,<br><br> - related haploidentical donors 3. Clinical center: National Medical Research Center<br> of pediatric haematology, oncology and immunology named after Dmitry Rogachev of<br> the Ministry of Health of Russia 4. Availability of consent to conduct a study<br><br>Exclusion Criteria:<br><br>Age over 21 years<br><br> - Patients with ALL outside clinical and hematological remission<br><br> - Clinical status:<br><br> - Lansky/Karnowski index <70% (supplement No.1)<br><br> - Heart function: left ventricular ejection fraction <40% according to ultrasound<br> of the heart1<br><br> - Kidney function: clearance of endogenous creatinine < 70 ml / min<br><br> - Liver function: total bilirubin, ALT, AST, ALP > 2 norms<br><br> - Lung function: lung capacity <50%, for children who cannot carry out of<br> respiratory function - oxygen saturation during pulse oximetry <92%<br><br> - Uncontrolled viral, fungal or bacterial infection.<br><br> - Mental illness of the patient or caregivers, making it impossible to realize the<br> essence of the study and compromising compliance with medical appointments and<br> sanitary and hygienic regime 1 These patients may receive treatment according to the<br> protocol, but the results will be evaluated separately

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the probability of developing acute GVHD stage II-IV after HSCT;side effects of conditioning;transplant-associated mortality

Secondary Outcome Measures

Name	Time	Method
cumulative probability of relapse;cumulative probability of relapse;event-free survival;event-free survival;Probability of engraftment of leukocyte;Probability of engraftment of platelet;Probability of reactivation of CMV;Probability of reactivation of EBV;Probability of reactivation of AdV;Probability of reactivation BK