Cumulative exposure to Fludarabine in patients undergoing reduced intensity allogeneic stem cell transplantation in Belgium

Patients undergoing allogeneic HSCT, for hematological malignancy, following RIC with Fludarabine, Melphalan and ATG.

Area under the curve (AUC) of F-Ara-A after exposure to Fludarabine in the context of reduced intensity conditioning with Fludarabine, Melphalan and anti-thymocyte globulin (ATG). To be assessed after the last included patient has finished conditioning regimen.

Association between F-Ara-A AUC and creatinine clearance; To be assessed after the last included patient has finished conditioning regimen, Association between F-Ara-A AUC and bodyweight/BMI; To be assessed after the last included patient has finished conditioning regimen., Influence of F-Ara-A AUC on non-relapse mortality, relapse rate, progression free survival and overall survival; To be assessed when: - the first 25 included patients have reached 1 year, 2 years and 3 years of follow-up post-transplant. - all included patients have reached 1 year, 2 years and 3 years of follow-up post-transplant., Influence of F-Ara-A AUC on median time to neutrophil and platelet engraftment; To be assessed when: - the first 25 included patients have reached 1 year of follow-up post-transplant. - all included patients have reached 1 year of follow-up post-transplant., Influence of F-Ara-A AUC on peripheral CD4 and CD8 T-cell count. To be assessed when: - the first 25 included patients have reached 1 year, 2 years and 3 years of follow-up post-transplant. - all included patients have reached 1 year, 2 years and 3 years of follow-up post-transplant., Influence of F-Ara-A AUC on incidence of central nervous system complications/events in the first year after allogeneic stem cell transplant., Applicability of pharmacokinetic model published by Langenhorst et al (6) on the study population to predict F-Ara-A AUC.

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Belgium