Background: Haploidentical hematopoietic cell transplantations (haplo-HCTs) with post-transplant cyclophosphamide (PT-Cy) are standard practice, but complications causing morbidity and mortality are not well described. Methods: The aim of this prospective non-interventional multicenter study was to document frequency of potential non-infectious and infection-related complications and main transplant outcomes after the first unmanipulated haplo-HCT with PT-Cy between 2017 and 2019 in 129 adult patients with hematological malignancies. The median follow-up was 37.3 months [95% CI: 34.3-39.7]. Results: The cumulative incidence (CI) of acute graft versus host disease (aGvHD) at day +100 was 22.4% grade II-IV [95% CI: 15.5-30.1] and 8.8% grade III-IV [95% CI: 4.6-14.6], respectively. The cumulative incidence of chronic GvHD (cGvHD) at 24 months was 25.8% [95% CI: 18.5-33.6]; extensive cGvHD was 10.9% [95% CI: 6.3-17.1], respectively. The most frequent non-infectious complications for the whole study population were mucositis-37.5% (n = 48); renal insufficiency-18% (n = 23); and cardiovascular complications-10.9% (n = 14). The following infection-related complications were diagnosed: bacterial in 84 (65.1%), viral in 66 (51.6%), and fungal in 24 (18.6%) recipients. Two-year OS was 58.1% [95% CI: 50.2-67.3]; NRM-27.1% [95% CI: 19.7-35]; PFS-50.4% [95% CI: 42.5-59.8]; and GRFS-38.8% [95% CI: 31.2-48.1]. About 50% of all deaths were directly caused by infection or infection-related conditions. Conclusions: Disease remission status at transplant significantly affected PFS, chronic GvHD, and GRFS. Although clinical applications of haplo-HCT with PTCy are widespread, the study confirms the need to reduce infection-related mortality after this type of GvHD prophylaxis.

Charité CVK University Medicine Berlin 13353 Berlin Germany

Charles University Hospital 32300 Pilsen Czech Republic

Comprehensive Cancer Centre King's College London London WC2R 2LS UK

Department of Hematology and Transplantation Şişli Memorial Hospital 34384 Istanbul Türkiye

Department of Hematology Hemostasis Oncology and Stem Cell Transplantation Hannover Medical School 30625 Hannover Germany

Department of Hematology Transplantation and Internal Medicine Medical University of Warsaw 02 091 Warsaw Poland

Dipartimento di Scienze Radiologiche ed Ematologiche Universita Cattolica S Cuore 00168 Rome Italy

EBMT Paris Study Unit Department of Haematology Saint Antoine Hospital INSERM UMR S 938 Sorbonne University 75012 Paris France

Faculty of Medicine Ahmed Benbella 1 University 31000 Oran Algeria

Faculty of Medicine Bahçeşehir University 34734 Istanbul Türkiye

Hospital Santa Creu i Sant Pau 08025 Barcelona Spain

Hospital Universitario Fundación Jiménez Díaz 28040 Madrid Spain

HUS Comprehensive Cancer Center 00029 Helsinki Finland

Institut Catalá d'Oncologia Hospital Duran i Reynals 199203 Barcelona Spain

RM Gorbacheva Research Institute Pavlov University 197022 St Petersburg Russia

University Hospital Basel 4031 Basel Switzerland

University Hospital Centre Rijeka and School of Medicine University of Rijeka 51000 Rijeka Croatia

University Hospital Gasthuisberg 3000 Leuven Belgium

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