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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 9-year-old girl developed Epstein Bar virus (EBV)-associated primary CNS post transplant disorder (PTLD) during treatment with mycophenolate mofetil for graft versus host disease (GvHD) prophylaxis.
The girl, who had been diagnosed with BCR‐ABL‐positive chronic myeloid leukaemia at the age of 9 years and failed to achieve complete response with tyrosine kinase inhibitor therapies, received haematopoietic stem cell transplantation (HSCT). She received conditioning regimen comprising busulfan, fludarabine and antithymocyte globulin. She received a cord blood graft. She was EBV‐seropositive, and the donor was EBV-seronegative. After graft failure, three months following HSCT, she received salvage haploidentical transplantation with a graft from her EBV seropositive mother. She...
- Kassa C, et al. Successful nivolumab therapy in an allogeneic stem cell transplant child with post-transplant lymphoproliferative disorder. Pediatric Transplantation 22: e13302, No. 8, Dec 2018. Available from: URL: http://doi.org/10.1111/petr.13302 - Hungary