Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Calcineurin Inhibitor at Patients With Hemoblastosis
NCT05515029 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2023-09-28
Summary
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
Conditions
- Acute Lymphoblastic Leukemia
- Myeloblastic Leukemia
- Biphenotypic Acute Leukemia
- Malignant Lymphoma
- Myelodysplastic Syndromes
- Juvenile Myelomonocytic Leukemia
Interventions
- COMBINATION_PRODUCT
-
GVHD prevention: post-transplantation cyclophosphamide, abatacept, vedolizumab, calcineurin inhibitor
Cyclophosphamide 100 mg/kg/course on the days +3, +4 Abatacept 10 mg/kg/day on the days +5, +14, +28, +45, +60, +90, +120 Vedolizumab 10 mg/kg/day, max. 300 mg on the days -1, +14, +28
Sponsors & Collaborators
-
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Day
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-23
- Primary Completion
- 2024-08-15
- Completion
- 2026-10-16
Countries
- Russia
Study Locations
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