Preventing of GVHD with Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Ruxolitinib At Children and Young Adults with Hemoblastosis
Recruiting now · Phase 2/Phase 3
Conditions studied: Biphenotypic Acute Leukemia, Acute Lymphoblastic Leukemia, Myeloblastic Leukemia, Bilinear Leukemia, Malignant Lymphoma, Non-Hodgkin, Myelodysplastic Syndrome
In brief
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
Key facts
- Study ID
- NCT06756152
- Run by
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- People needed
- 50
- Starts
- 2024-07-10
- Expected to finish
- 2026-10-10
- Last updated by the study team
- 2025-01-01
Who can join
Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients under the age of 21 years with following diseases:
- acute lymphoblastic,
- myeloblastic,
- biphenotypic,
- bilinear leukemia,
- malignant lymphoma,
- myelodysplastic syndrome,
You may not qualify if…
- 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
Where it is running
- National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov — Moscow, Russia (enrolling)
Full record on ClinicalTrials.gov
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