Prof Elias Jabbour MD, Federico Lussana MD, Pilar Martínez-Sánchez MD, Anna Torrent MD, José J Rifón MD, Vaibhav Agrawal MD, Mar Tormo MD, Ryan D Cassaday MD, Thomas Cluzeau MD, Françoise Huguet MD, Cristina Papayannidis MD, Jesús M Hernández-Rivas MD, Anita Rijneveld MD, Shaun Fleming MD, Vladan Vucinic MD, Boris Böll MD, Takayuki Ikezoe MD, Maher Abdul-Hay MD, Mary L Savoie MD, Andre C Schuh MD, Celine Berthon MD, Stefan Schwartz MD, Sabina Chiaretti MD, Junichiro Yuda MD, Takuya Miyazaki MD, José González-Campos MD, Yuqi Chen PhD, Hansen Wong PhD, Jessica Choudhry PharmD, Gerhard Zugmaier MD, Erin Guest MD, Paul Gordon MD, Prof Hagop Kantarjian MD
{"title":"Subcutaneous blinatumomab in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: post-hoc safety and activity analysis from a multicentre, single-arm, phase 1/2 trial","authors":"Prof Elias Jabbour MD, Federico Lussana MD, Pilar Martínez-Sánchez MD, Anna Torrent MD, José J Rifón MD, Vaibhav Agrawal MD, Mar Tormo MD, Ryan D Cassaday MD, Thomas Cluzeau MD, Françoise Huguet MD, Cristina Papayannidis MD, Jesús M Hernández-Rivas MD, Anita Rijneveld MD, Shaun Fleming MD, Vladan Vucinic MD, Boris Böll MD, Takayuki Ikezoe MD, Maher Abdul-Hay MD, Mary L Savoie MD, Andre C Schuh MD, Celine Berthon MD, Stefan Schwartz MD, Sabina Chiaretti MD, Junichiro Yuda MD, Takuya Miyazaki MD, José González-Campos MD, Yuqi Chen PhD, Hansen Wong PhD, Jessica Choudhry PharmD, Gerhard Zugmaier MD, Erin Guest MD, Paul Gordon MD, Prof Hagop Kantarjian MD","doi":"10.1016/s2352-3026(25)00144-9","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00144-9","url":null,"abstract":"Two doses of subcutaneous blinatumomab in patients with relapsed or refractory B-cell acute lymphoblastic leukaemia were identified as preliminary recommended phase 2 doses, based on the dose-escalation phase of this multicentre single-arm, phase 1/2 trial. Here, we aim to further study the safety, activity, and pharmacokinetics of these doses in all participants who have received them, including those treated in the completed phase 1b expansion part of the study.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"44 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144305091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Much to hope for in blood donation","authors":"The Lancet Haematology","doi":"10.1016/s2352-3026(25)00173-5","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00173-5","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"51 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144305108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Omran Saifi,Chelsea C Pinnix,Chris R Kelsey,Leslie K Ballas,Sarah A Milgrom,Ranjana Advani,Margaret T Kasner,Stella Flampouri,Stephanie A Terezakis,Mark Sellmyer,John P Plastaras,Bradford S Hoppe
{"title":"Radiate equity: the inclusion of radiation oncology and other specialties in lymphoma collaborative groups.","authors":"Omran Saifi,Chelsea C Pinnix,Chris R Kelsey,Leslie K Ballas,Sarah A Milgrom,Ranjana Advani,Margaret T Kasner,Stella Flampouri,Stephanie A Terezakis,Mark Sellmyer,John P Plastaras,Bradford S Hoppe","doi":"10.1016/s2352-3026(25)00080-8","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00080-8","url":null,"abstract":"There has been a notable decrease in the use of radiation in lymphoma clinical practice and research in recent years. The NRG Hematologic Malignancies Working Group aimed to assess the inclusion of radiation oncology alongside haematology and oncology, pathology and molecular biology, and diagnostic radiology and nuclear medicine in lymphoma academic leadership positions. The haematology and oncology specialty had the highest representation among National Comprehensive Cancer Network lymphoma guideline committees, lymphoma research cooperative groups, lymphoma research foundations, and the editorial boards of seven high-impact haematology journals, with under-representation of radiation oncology and other specialties, such as diagnostic radiology and nuclear medicine. The NRG Hematologic Malignancies Working Group advocates for increased multidisciplinary representation and collaboration to enhance the quality of care and improve outcomes for patients with lymphoma.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144097806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Low-dose moderate hypofractionated radiotherapy for indolent non-Hodgkin lymphoma: a multicentre, single-arm, phase 2 trial.","authors":"Xin-Yue Wang,Xi-Mei Zhang,Liang Wang,Lin-Rui Gao,Ke Chen,Xiao-Li Feng,Wei Rao,Rong Zheng,Yun-Peng Wu,Yong-Wen Song,Hui Fang,Bo Chen,Jing Jin,Yue-Ping Liu,Hao Jing,Yuan Tang,Wen-Wen Zhang,Yi-Rui Zhai,Ning-Ning Lu,Ning Li,Chang-Fa Xia,Shu-Lian Wang,Xin Liu,Ye-Xiong Li,Shu-Nan Qi","doi":"10.1016/s2352-3026(25)00071-7","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00071-7","url":null,"abstract":"BACKGROUNDRadiotherapy for indolent non-Hodgkin lymphoma has evolved to optimise the definitive dose while minimising toxicity. We aimed to assess the activity and safety of a hypofractionated low-dose radiotherapy regimen of 12 Gy in four fractions in patients with indolent non-Hodgkin lymphoma.METHODSThis multicentre, single-arm, phase 2 trial study enrolled patients from four hospitals in China. Patients aged 18 years or older with newly diagnosed or relapsed stage I-IV indolent non-Hodgkin lymphoma (follicular lymphoma, marginal zone lymphoma, and low-grade lymphoma) and an Eastern Cooperative Oncology Group performance status of 0-3 were eligible. Patients underwent involved-site radiotherapy at a dose of 12 Gy in four fractions. The primary endpoint was the complete response rate 6 months after radiotherapy. All analyses were performed in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT05543070, with a four-month delay due to the COVID-19 pandemic; recruitment is complete and follow-up is ongoing.FINDINGSBetween May 8, 2022, and Nov 8, 2023, 71 patients (with 73 target sites) were enrolled (median age 55 years [IQR 48-65]; 29 [41%] male and 42 [59%] female; and all were Asian). With a median follow-up of 19 months (IQR 16-22), the 6-month complete response was 95% (95% CI 87-98; 69 of 73 sites). The most common acute adverse events were grade 1 lymphopenia (20 [28%] of 71 patients) and grade 1 nausea (14 [19%] of 73 sites). The sole grade 3 or higher adverse event was grade 3 lymphopenia (eight [11%] of 71 patients). No treatment-related deaths were noted.INTERPRETATIONThe regimen of 12 Gy in four fractions is safe and shows promising activity as a local treatment for patients with indolent non-Hodgkin lymphoma. Given the retrospective registration of the trial, further studies evaluating the efficacy of this strategy are warranted.FUNDINGThe Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, the National High Level Hospital Clinical Research Funding, and the Beijing Hope Run Special Fund of Cancer Foundation of China.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael Northend,William Wilson,Kushani Ediriwickrema,Laura Clifton-Hadley,Wendi Qian,Zaynab Rana,Tanya-Louise Martin,William Townsend,Moya Young,Fiona Miall,David Cunningham,Jan Walewski,Burhan Ferhanoglu,Kim Linton,Amanda Johnston,John F Seymour,David C Linch,Kirit M Ardeshna
{"title":"Early rituximab monotherapy versus watchful waiting for advanced stage, asymptomatic, low tumour burden follicular lymphoma: long-term results of a randomised, phase 3 trial.","authors":"Michael Northend,William Wilson,Kushani Ediriwickrema,Laura Clifton-Hadley,Wendi Qian,Zaynab Rana,Tanya-Louise Martin,William Townsend,Moya Young,Fiona Miall,David Cunningham,Jan Walewski,Burhan Ferhanoglu,Kim Linton,Amanda Johnston,John F Seymour,David C Linch,Kirit M Ardeshna","doi":"10.1016/s2352-3026(25)00034-1","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00034-1","url":null,"abstract":"BACKGROUNDInitial results of this study, reported after a median follow-up close to 4 years, demonstrated improved time to initiation of new treatment (TTNT) for patients with advanced stage, asymptomatic, low tumour burden follicular lymphoma who received early rituximab monotherapy when compared with watchful waiting. Given the long natural history of follicular lymphoma, the trial was extended to further assess TTNT with longer follow-up. Mature data are presented here.METHODSIn this open-label, randomised, phase 3 trial, conducted at 118 centres in five countries, adult patients with asymptomatic, stage II-IV, grade 1-3a low tumour burden follicular lymphoma and Eastern Cooperative Oncology Group performance status 0-1 were randomly assigned (1:1:1) between watchful waiting, rituximab induction (375 mg/m2, intravenous) weekly for four doses (rituximab induction group) and rituximab induction followed by rituximab maintenance at the same dose every 8 weeks for 12 doses (rituximab maintenance group). The rituximab induction group closed early on Sept 30, 2007, and the study was amended to a two-arm trial. The primary endpoint was TTNT, assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT00112931, and recruitment and follow-up are complete.FINDINGSBetween Oct 15, 2004, and May 1, 2009, 455 patients were randomly assigned, including 183 to watchful waiting, 82 to rituximab induction, and 190 to rituximab maintenance. Median follow-up was 14·7 years (IQR 13·3-15·6). At 15 years, 65% (95% CI 56-72) of patients in the rituximab maintenance group, 48% (36-60) in the rituximab induction group, and 34% (27-42) in the watchful waiting group had not started new treatment. Median TTNT was not yet reached (95% CI 15·6-not estimable) in the rituximab maintenance group, 14·8 years (7·5-not reached) in the rituximab induction group, and 5·6 years (3·8-8·4) in the watchful waiting group. TTNT was longer in both the rituximab induction and rituximab maintenance groups compared with the watchful waiting group (rituximab induction vs watchful waiting: hazard ratio [HR] 0·55 [95% CI 0·38-0·80], p=0·0019; rituximab maintenance vs watchful waiting: HR 0·36 [0·26-0·50], p<0·0001).INTERPRETATIONThese mature data with 15 years of follow-up confirm that early rituximab monotherapy substantially delays the need for new treatment for patients with advanced stage, asymptomatic low tumour burden follicular lymphoma, providing an evidence base for its use in this setting and confirming its value for patients who seek to defer or avoid treatment with chemotherapy.FUNDINGCancer Research UK, Lymphoma Research Trust, Lymphoma Association, and Roche.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"2 1","pages":"e335-e345"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ashley E Benson,Jamie O Lo,Maureen O Achebe,Jorgeane S Aslan,Michael Auerbach,Bethany T Samuelson Bannow,Marie J Boller,Thomas G Deloughery,Jacquelin Dingman,Layla Van Doren,Geolani W Dy,Patricia A Ford,Jason A Freed,Michael K Georgieff,Kristina M Haley,Chloe I Han,Adam K Lewkowitz,Kylee L Martens,Robert T Means,Elizabeta Nemeth,Sven R Olson,Jacquelyn M Powers,Kristin C Prewitt,Toby Richards,Don C Rockey,Eric J Roeland,Kimberly S Ryan,Hanny Al-Samkari,Michelle Sholzberg,Methodius G Tuuli,Angela C Weyand,Michelle P Zeller,Annette M Totten,Ilya Ivlev,Joseph J Shatzel,
{"title":"Management of iron deficiency in children, adults, and pregnant individuals: evidence-based and expert consensus recommendations.","authors":"Ashley E Benson,Jamie O Lo,Maureen O Achebe,Jorgeane S Aslan,Michael Auerbach,Bethany T Samuelson Bannow,Marie J Boller,Thomas G Deloughery,Jacquelin Dingman,Layla Van Doren,Geolani W Dy,Patricia A Ford,Jason A Freed,Michael K Georgieff,Kristina M Haley,Chloe I Han,Adam K Lewkowitz,Kylee L Martens,Robert T Means,Elizabeta Nemeth,Sven R Olson,Jacquelyn M Powers,Kristin C Prewitt,Toby Richards,Don C Rockey,Eric J Roeland,Kimberly S Ryan,Hanny Al-Samkari,Michelle Sholzberg,Methodius G Tuuli,Angela C Weyand,Michelle P Zeller,Annette M Totten,Ilya Ivlev,Joseph J Shatzel,","doi":"10.1016/s2352-3026(25)00038-9","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00038-9","url":null,"abstract":"Iron deficiency is the most common micronutrient deficiency worldwide. Oral iron is often recommended as first-line treatment, but there is no consensus on the optimal formulation, dosing strategy, or which patients should be treated preferentially with intravenous iron. To address these challenges, the Iron Consortium at Oregon Health & Science University (OHSU) convened an international panel of 26 experts in haematology, primary care, paediatrics, obstetrics, gastroenterology, cancer, and patient advocacy among its members. This panel was supplemented by insights from a four-person patient focus group to develop current recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. The panel developed clinically relevant questions in five priority topic areas, a systematic literature search was performed, and studies meeting a priori criteria were included to generate evidence tables for recommendation development. Evidence-based and expert opinion-based recommendations were made through a structured anonymous consensus voting process at an in-person meeting in Portland, OR, USA, hosted by OHSU on Feb 16-17, 2024. The expert panel made seven evidence-based recommendations for three demographic groups with iron deficiency: non-pregnant adults, pregnant individuals, and infants, children, and adolescents. Expert opinions supported the recommendations on 21 aspects of care for which there is insufficient evidence. This Review provides evidence-based recommendations and expert consensus on the diagnosis, treatment, and management of iron deficiency, detailing best practices for oral and intravenous iron repletion across diverse patient populations.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"13 1","pages":"e376-e388"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rituximab versus active surveillance in patients with follicular lymphoma.","authors":"Eva Kimby","doi":"10.1016/s2352-3026(25)00105-x","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00105-x","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"114 1","pages":"e320-e321"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}