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https://wslhd.intersearch.com.au/wslhdjspui/handle/1/14528| Title: | Blinatumomab in de novo AYA ALL—Results of the Australasian Leukaemia and Lymphoma Group ALL09 “SUBLIME” study |
| Authors: | Greenwood, M.;Gangatharan, S.;Osborn, M.;Ng, A. P.;Fleming, S.;Fedele, P.;Trahair, T.;Casey, J.;Mapp, S.;Cheung, C.;Armytage, T.;Henderson, M.;Sutton, R.;Rehn, J.;Page, E.;Heatley, S.;Button, P.;Rowley, L.;Larsen, S. R.;Presgrave, P.;Kwan, John M.;Bennett, S.;Fong, C. Y.;Dalla-Pozza, L.;Yeung, D.;White, D. |
| WSLHD Author: | Kwan, John M. |
| Subjects: | Haematology;Oncology;Paediatrics |
| Issue Date: | 2026 |
| Citation: | HemaSphere. 10(1):e70291, 2026 Jan |
| Abstract: | Pediatric regimens improve outcomes in adolescent and young adult (AYA) acute lymphoblastic leukemia (ALL) patients. End-consolidation (time point 2 [TP2]) minimal residual disease negativity (MRDneg) is associated with improved survival. In this study, standard consolidation chemotherapy was replaced with blinatumomab to improve TP2 MRDneg—a key survival surrogate in B-lineage ALL. From 2019 to 2022, 55 patients constituted the intention-to-treat (ITT) cohort, median age 25 (range, 16–39) years. Using a Simon's 2-stage design, blinatumomab replaced standard consolidation chemotherapy cycles with TP2 MRDneg as the primary endpoint. Blinatumomab was associated with an improved TP2 MRDneg rate of 70.8% (95% CI, 55.9%–83.0%) versus the null hypothesis of 60% (P = 0.037). When compared to our previous ALL06 study, median time from protocol I commencement to next treatment phase was 84 versus 97 days (P = 0.0001), with 82.7% versus 45.1% (P < 0.0001), commencing protocol M or high-risk block therapy by day 94. Induction mortality was 1.8%. Blinatumomab was well tolerated. Median follow-up was 42.9 (range, 1.9–54.7) months, with 3-year disease-free survival (DFS) 88.6% (95% CI, 76.3%–94.7%) and 3-year overall survival (OS) 90.5% (95% CI, 78.6%–95.9%) in the ITT cohort. Higher than medium-risk patients had poorer DFS but not OS. Standard genomic risk patients had 100% 3-year DFS and OS. Adverse genomic risk stratified by TP2 MRDpos predicted poorer DFS but not OS. Blinatumomab consolidation for de novo B-lineage AYA ALL was associated with high MRDneg rates and excellent survival, particularly in standard-risk disease. Genomics may assist in predicting response to blinatumomab in de novo ALL. |
| URI: | https://wslhd.intersearch.com.au/wslhdjspui/handle/1/14528 |
| DOI: | https://doi.org/10.1002/hem3.70291 |
| Journal: | HemaSphere |
| Type: | Journal Article |
| Study or Trial: | Major Clinical Study Retrospective Study |
| Department: | Haematology |
| Facility: | Auburn Blacktown Westmead |
| Affiliated Organisations: | University of Sydney, Sydney, NSW, Australia Department of Haematology, Royal North Shore Hospital, Sydney, NSW, Australia Fiona Stanley Hospital, Perth, WA, Australia University of Western Australia, Perth, WA, Australia Department of Haematology & Oncology, Women's & Children's Hospital, Adelaide, SA, Australia Youth Cancer Service, Royal Adelaide Hospital, Adelaide, SA, Australia Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia Department of Clinical Haematology, The Royal Melbourne Hospital and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia The Alfred Hospital and Monash University, Melbourne, VIC, Australia Monash Hospital, Melbourne, VIC, Australia Sydney Children's Hospital, Randwick, NSW, Australia Paediatrics and Child Health, UNSW Medicine & Health, University of New South Wales, Sydney, NSW, Australia The Townsville Hospital, Townsville, QLD, Australia Princess Alexandra Hospital, Brisbane, QLD, Australia Prince of Wales Hospital, Sydney, NSW, Australia Gosford Hospital, Gosford, NSW, Australia Children's Cancer Institute, University of NSW, Randwick, NSW, Australia Precision Cancer Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, SA, Australia McCloud Consulting Group, Sydney, NSW, Australia Australasian Leukaemia and Lymphoma Group, Richmond, VIC, Australia Institute of Haematology, Royal Prince Alfred Hospital, Sydney, NSW, Australia Wollongong Hospital, Wollongong, NSW, Australia Department of Haematology and Blood Transplant and Cellular Therapies Program, Westmead Hospital, Sydney, NSW, Australia The Canberra Hospital, Canberra, ACT, Australia Department of Haematology, Austin Hospital, Heidelberg, VIC, Australia The University of Melbourne, Melbourne, VIC, Australia The Children's Hospital at Westmead, Sydney, NSW, Australia Department of Haematology, Royal Adelaide Hospital, Adelaide, SA, Australia |
| Keywords: | adolescent allogeneic stem cell transplantation B cell acute lymphoblastic leukemia cancer chemotherapy cancer regression cancer survival clinical protocol confidence interval consolidation chemotherapy drug response drug tolerability genomics high risk patient minimal residual disease multiple cycle treatment null hypothesis young adult asparaginase macrogol blinatumomab cyclophosphamide cytarabine mercaptopurine methotrexate tioguanine |
| Appears in Collections: | WSLHD publications |
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