Clinical trial · Interventional
Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib 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 Baricitinib 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 and Baricitinib 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
Conditions (5)
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 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Biphenotypic Acute Leukemia | — | UNRESOLVED | — |
| Malignant Lymphoma | Lymphoma | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baricitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Baricitinib and Cyclophosphamide
- description
- Baricitinib 4 mg/day per os (patient age \> 9 years), 2 mg/day (patient age \< 9 years), from day -3 to day +90 (after HSCT), orally, once a day.
- interventionNames
- Drug: Baricitinib
Primary outcomes (3)
- measure
- Estimate the probability of developing acute GVHD stage II-IV after HSCT
- timeFrame
- 100 days after HSCT
- measure
- side effects of conditioning
- timeFrame
- 100 days after HSCT
- description
- Explore the safety based on an assessment of the frequency of occurrence of: \- severe (3-5 degrees) side effects of conditioning during 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: following diseases: * acute lymphoblastic, * myeloblastic, * biphenotypic, * bilinear leukemia, * malignant lymphoma, * myelodysplastic syndrome, 2. Donors: * voluntary fully HLA-matched unrelated, * related haploidentical donors 3. Clinical center: National Medical Research Center of pediatric haematology, oncology and immunology named after Dmitry Rogachev" of the Ministry of Health of Russia 4. Availability of consent to conduct a study 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