{"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}
{"title":"Molecular monitoring versus standard clinical care in younger adults with acute myeloid leukaemia: results from the UK NCRI AML17 and AML19 randomised, controlled, phase 3 trials.","authors":"Nicola Potter,Jelena Jovanovic,Adam Ivey,Jad Othman,Abin Thomas,Amanda Gilkes,Manohursingh Runglall,Anju Kanda,Ian Thomas,Sean Johnson,Joanna Canham,William Villiers,Steven Knapper,Asim Khwaja,Mary Frances McMullin,Jamie Cavenagh,Ulrik Malthe Overgaard,Richard E Clark,Ellen Solomon,Sylvie D Freeman,Robert Hills,Alan Burnett,Nigel Russell,Richard Dillon,","doi":"10.1016/s2352-3026(25)00037-7","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00037-7","url":null,"abstract":"BACKGROUNDIn patients with acute myeloid leukaemia treated with curative intent, the detection of measurable residual disease (MRD) generally confers a poor prognosis. This study aimed to identify whether altering treatment based on MRD results can improve survival.METHODSIn the UK NCRI AML17 and AML19 randomised, controlled, phase 3 trials, performed in the UK, Denmark, and New Zealand, we screened patients aged 16-60 years with newly diagnosed acute myeloid leukaemia for molecular markers suitable for disease monitoring, including NPM1 mutations and fusion genes. Patients with a marker were randomly assigned (2:1) to either sequential molecular MRD monitoring during treatment and for 3 years after, or standard clinical care only with no molecular monitoring. In the monitoring group, treating physicians decided whether and how to incorporate the MRD results into the patient's therapy, including in cases of MRD relapse. The primary endpoint was overall survival. Prespecified subgroup analysis of the primary outcome included analysis by molecular group (NPM1mut with FLT3-ITD, NPM1mut without FLT3-ITD, and fusion gene transcripts). Both trials were registered with ISRCTN, ISRCTN55675535 and ISRCTN78449203, and are completed.FINDINGSIn the AML17 trial, 1836 patients were enrolled between June 1, 2012 and Dec 31, 2014. In the AML19 trial, 965 patients were enrolled between Nov 9, 2015, and Jan 23, 2018. 637 patients were randomly assigned across both trials (289 to MRD monitoring and 144 to no monitoring in AML17 and 136 to MRD monitoring and 68 to no monitoring in AML19). With a median follow-up time of 4·9 years (IQR 3·6-5·9), overall survival at 3 years was 70% (95% CI 66-75) in patients in the monitoring group and 73% (68-80) in patients in the no-monitoring group. Meta analysis of the two studies showed no difference in overall survival (hazard ratio [HR] 1·11, 95% CI 0·83-1·49; p=0·25). In the pre-specified subgroup analysis of the primary endpoint, overall survival at 3 years in patients with both NPM1 and FLT3 internal tandem duplication (ITD) mutations was 69% (95% CI 60-79) in the monitoring group and 58% (45-74) in the no-monitoring group (HR 0·53, 95% CI 0·31-0·91; p=0·021). However there was no difference in survival by randomisation in patients with NPM1 mutations without FLT3-ITD (overall survial 69% [95% CI 62-77] in the monitoring group and 78% [70-87] in the no monitoring group; HR 1·56, 95% CI 0·96-2·52) or those with fusion gene transcripts (overall survial 72% [95% CI 65-79] in the monitoring group and 77% [68-87] in the no monitoring group; HR 1·28, 95% CI 0·80-2·18).INTERPRETATIONSequential molecular MRD monitoring, coupled with MRD-guided treatment, did not improve overall survival in the entire study population; however, in the subgroup of patients with baseline NPM1 and FLT3 ITD mutations, we observed a survival benefit for MRD monitoring.FUNDINGNational Institute for Health Research, Blood Cancer UK, and Cancer Research UK.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"48 1","pages":"e346-e356"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897466","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":"Is there still a role for CNS prophylaxis in diffuse large B-cell lymphoma?","authors":"Jeffery Smith","doi":"10.1016/s2352-3026(25)00110-3","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00110-3","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"90 1","pages":"e332-e333"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897472","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}
Malgorzata Mikulska,Florian van Bömmel,Charlotte Mouliade,Giuseppe Indolfi,Helenie Kefalakes,Marie von Lilienfeld-Toal,Sven Pischke,Olivier Hermine,Darius Moradpour,Heiner Wedemeyer,Thomas Berg,Per Ljungman,Vincent Mallet
{"title":"Updated recommendations for the management of hepatitis B, C, and E virus infections in patients with haematological malignancies and those undergoing haematopoietic cell transplantation: recommendations from the 9th European Conference on Infections in Leukaemia (ECIL-9).","authors":"Malgorzata Mikulska,Florian van Bömmel,Charlotte Mouliade,Giuseppe Indolfi,Helenie Kefalakes,Marie von Lilienfeld-Toal,Sven Pischke,Olivier Hermine,Darius Moradpour,Heiner Wedemeyer,Thomas Berg,Per Ljungman,Vincent Mallet","doi":"10.1016/s2352-3026(25)00049-3","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00049-3","url":null,"abstract":"Viral hepatitis remains a global health challenge and immune status affects outcomes. In patients with haematological malignancies, including haematopoietic stem-cell transplantation recipients, viral hepatitis can be life-threatening due to the direct effects of the virus or the need to modify or delay chemotherapy. Additionally, haematopoietic stem-cell donors with past or current viral hepatitis infections might transmit the virus to recipients. The growing recognition of hepatitis E virus (HEV), advances in haematological therapies, and the availability of direct-acting antivirals for hepatitis C virus (HCV), led the 2022 9th European Conference on Infections in Leukaemia (ECIL-9) to update the 2013 ECIL-5 guidelines on viral hepatitis. The ECIL organising committee convened a panel of 13 impartial international experts (all authors of this Review) in viral hepatitis, both within and outside the fields of haematological malignancies and immunosuppression. The ECIL-9 panel conducted a review of the literature on hepatitis B virus (HBV), HCV, and HEV, grading the evidence based on the European Society for Clinical Microbiology and Infectious Diseases system. The panel identified key clinical questions and outcomes and built on the recommendations established during ECIL-5. A consensus conference was held in Sofia Antipolis, France, from Sept 15-17, 2022, bringing together 49 experts from 19 countries. The ECIL-9 panel presented the proposed recommendations, which were revised following expert discussions. A final consensus on updated guidelines was reached in a second plenary session. The updated ECIL-9 guidelines provide evidence-based recommendations on the prevention, screening, treatment, and long-term surveillance of viral hepatitis in patients with haematological malignancies and haematopoietic cell transplantation recipients.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"90 1","pages":"e389-e399"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897458","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}