Clinical trial · Interventional
Preventing of GVHD with Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Ruxolitinib At Children and Young Adults with Hemoblastosis
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 Ruxolitinib At Children and Young Adults with Hemoblastosis After Hematopoietic Stem Cell Transplantation from an Unrelated or Haploidentic Donor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Bilinear Leukemia | — | UNRESOLVED | — |
| Biphenotypic Acute Leukemia | — | UNRESOLVED | — |
| Malignant Lymphoma, Non-Hodgkin | Lymphoma | ALIAS | 0.85 |
| Myeloblastic Leukemia | — | UNRESOLVED | — |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conditioning regimen: Treosulfan 42 g/m2/course or total body irradiation 12 Gray/course, Etoposide 60 mg/kg , Fludarabine 150 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention of GVHD: Cyclophosphamide, Abatacept, Vedolizumab, Ruxolitinib
- description
- 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
- interventionNames
- Drug: Conditioning regimen: Treosulfan 42 g/m2/course or total body irradiation 12 Gray/course, Etoposide 60 mg/kg , Fludarabine 150
Primary outcomes (5)
- measure
- 1. Cumulative Incidence stage II-IV after HSCT
- timeFrame
- up to 100 days
- description
- Estimate the probability of developing acute GVHD stage II-IV after HSCT-
- measure
- Kaplan Meier overal survival
- timeFrame
- up to 100 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available