Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricit… (NCT06475820) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis
Russia150 participantsStarted 2023-12-01
Plain-language summary
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
Who can participate
Age range1 Day – 21 Years
SexALL
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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
What they're measuring
1
Estimate the probability of developing acute GVHD stage II-IV after HSCT
Timeframe: 100 days after HSCT
2
side effects of conditioning
Timeframe: 100 days after HSCT
3
transplant-associated mortality
Timeframe: 100 days after HSCT
Trial details
NCT IDNCT06475820
SponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology