No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 Day – 21
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Other
Who this trial is looking for
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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
Trial Locations
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Status
Eligibility Criteria
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 hemato…
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
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