The graft-versus-leukaemia effect (GVL) is closely associated with graft-versus-host disease (GVHD) after human leucocyte antigen (HLA)-matched allogeneic stem-cell transplantation (SCT) in acute lymphoblastic leukaemia (ALL). However, there are no data on this association following haploidentical SCT (haploSCT) with post-transplant cyclophosphamide (PTCy). We assessed the impact of acute and chronic GVHD on haploSCT outcomes in 516 adult ALL patients. The cumulative incidence of acute GVHD grade II-IV and III-IV, chronic GVHD and extensive chronic GVHD was 33.3%, 11.7%, 35.3% and 11.8% respectively. The 2-year relapse incidence (RI), non-relapse mortality (NRM) and overall survival (OS) were 27.1%, 17.3% and 64.4% respectively. The time-dependent hazard ratios (HRs) of acute GVHD grade II, grade III-IV, limited and extensive chronic GVHD associated with RI were 0.92 (95% confidence interval [CI] 0.58-1.48, p = 0.74), 0.57 (95% CI, 0.27-1.22, p = 0.15), 1.06 (95% CI, 0.62-1.82, p = 0.83) and 0.95 (95% CI, 0.42-2.17, p = 0.91) respectively. Acute GVHD grade III-IV and extensive chronic GVHD were associated with higher NRM (hazard ratio [HR] 1.95 [95% CI, 1.09-3.48, p = 0.002] and 3.3 [95% CI, 1.41-7.73, p = 0.006]) and reduced OS (HR 1.91 [95% CI, 1.07-3.39, p = 0.03] and 3.27 [95% CI, 1.4-7.66, p = 0.006]) respectively. In conclusion, acute and chronic GVHD are not statistically associated with reduced RI after haploSCT with PTCy in ALL. Higher GVHD grades are associated with higher NRM and lower OS.

BMT Unit Haematology Research Laboratory Training and Medical Haematology Division Baskent University Hospital Adana Turkey

Bone Marrow Transplant Unit Medicana International Hospital Istanbul Istanbul Turkey

Bone Marrow Transplantation Department Anadolu Medical Center Hospital Kocaeli Turkey

Department of Hematology BMT Hopital St Louis Paris France

Department of Internal Medicine 3 University Hospital of Munich Campus Grosshadern LMU Munich Germany

Division of Hematology Chaim Sheba Medical Center Tel Hashomer and Gray Faculty of Medical and Health Sciences Tel Aviv University Tel Aviv Israel

Hématologie Clinique et Thérapie Cellulaire Hôpital Saint Antoine Paris France

Hematology and Bone Marrow Transplant Unit San Raffaele Scientific Institute Milan Italy

Hematology and Hematopoietic SCT Unit Sisli Memorial Hospital Istanbul Turkey

Institute of Hematology and Blood Transfusion Prague Czech Republic

Ospedale San Gerardo Clinica Ematologica dell'Universita Milano Biocca Monza Italy

Programme de Transplantation and Therapie Cellulaire Centre de Recherche en Cancérologie de Marseille Institut Paoli Calmettes Marseille France

Sorbonne University INSERM UMRs 938 Paris France

Universita Cattolica S Cuore Istituto di Ematologia Ematologia Rome Italy

UO Ematologia e Terapie Cellulari IRCCS Ospedale Policlinico San Martino Genoa Italy

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