Hanqi Luo,Lei Liu,Melissa F Young,Parminder S Suchdev,
{"title":"The effects of revised haemoglobin cutoffs on the global burden of anaemia.","authors":"Hanqi Luo,Lei Liu,Melissa F Young,Parminder S Suchdev,","doi":"10.1016/s2352-3026(25)00052-3","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00052-3","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"70 1","pages":"e325-e326"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897314","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":"Lessons from EINSTEIN-Jr and next steps for extended-phase anticoagulation in paediatric venous thromboembolism.","authors":"Lesley Mitchell,Vilmarie Rodriguez","doi":"10.1016/s2352-3026(25)00109-7","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00109-7","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"1 1","pages":"e321-e323"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897471","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":"Anti-GPRC5D CAR T-cell therapy as a salvage treatment in patients with progressive multiple myeloma after anti-BCMA CAR T-cell therapy: a single-centre, single-arm, phase 2 trial.","authors":"Jieyun Xia,Qian Sun,Dian Zhou,Hujun Li,Ying Wang,Yuekun Qi,Jiang Cao,Zhiling Yan,Depeng Li,Hai Cheng,Wei Sang,Feng Zhu,Haiying Sun,Wei Chen,Kunming Qi,Dongmei Yan,Tingting Qiu,Tingyu Hu,Weiying Gu,Jun Qian,Fan Xia,Na Qi,Congqian Jin,Yang Liu,Xue Wang,Yanlei Zhang,Shuixiu Peng,Zhenyu Li,Alex H Chang,Kailin Xu","doi":"10.1016/s2352-3026(25)00048-1","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00048-1","url":null,"abstract":"BACKGROUNDFor patients with multiple myeloma progression after anti-BCMA chimeric antigen receptor (CAR) T-cell therapy, the optimal salvage treatment strategies remain unclear. GPRC5D-directed CAR T cell might be a potential option. The aim of this trial was to investigate the activity and safety of anti-GPRC5D CAR T cells in patients with progressive multiple myeloma after anti-BCMA CAR T-cell therapy.METHODSIn this phase 2, open-label, single-arm, phase 2 trial, at the Affiliated Hospital of Xuzhou Medical University in China, we enrolled patients (aged 18-70 years old) with relapsed or refractory multiple myeloma who had progressed disease after anti-BCMA CAR T-cell therapy and a life expectancy of more than 12 weeks without active infections, serious liver, heart, or other diseases. Patients were assigned to receive a single dose of intravenous anti-GPRC5D CAR T cell at 2 × 106 cells per kg. The primary endpoint was the overall response rate, including stringent complete response, complete response, very good partial response, and partial response, according to the standard International Myeloma Working Group response assessment criteria. Activity and safety analyses were done in the patients who received a dose of anti-GPRC5D CAR T cell as defined in the protocol. This trial is registered with the Chinese Clinical Trial Registration Center, ChiCTR2100048888, and is ongoing.FINDINGSBetween Dec 1, 2021, and May 1, 2024, 42 patients were screened, 37 were enrolled and received anti-GPRC5D CAR T-cell therapy. Median age was 59 years (IQR 51-65), 17 (46%) of 37 patients were male and 20 (54%) female. All patients were Asian. At a median follow-up of 12·6 months (IQR 8·2-20·8), the overall response rate was 84% (95% CI 68-94, 31 of 37 patients), including 13 (35%) complete responses or better. The most common grade 3-4 adverse events were haematological toxicities, including leukopenia (34 [92%] of 37 patients), lymphopenia (36 [97%]), neutropenia (29 [78%]), anaemia (23 [62%]), and thrombocytopenia (23 [62%]). 26 (70%) of 37 patients had cytokine release syndrome, which was of grade 3 in two (5%) patients. One case of grade 1 immune effector cell-associated neurotoxicity syndrome was observed. There were no treatment-related deaths in the trial.INTERPRETATIONAnti-GPRC5D CAR T-cell salvage therapy induced a high response rate, and could be a potential treatment option in relapsed or refractory multiple myeloma patients who have progressed after anti-BCMA CAR T-cell treatment. Further investigations are warranted to establish the long-term efficacy and safety of this therapeutic approach.FUNDINGNational Natural Science Foundation of China and the General Project of Jiangsu Commission of Health.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143836509","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}
Niels W C J van de Donk,Carlos Fernandez de Larrea
{"title":"Sequential CAR T-cell therapy in myeloma: going from BCMA to GPRC5D.","authors":"Niels W C J van de Donk,Carlos Fernandez de Larrea","doi":"10.1016/s2352-3026(25)00074-2","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00074-2","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"294 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143836539","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":"Breaking sex biases: access for all in haemophilia care.","authors":"The Lancet Haematology","doi":"10.1016/s2352-3026(25)00112-7","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00112-7","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143853087","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}
Christoph Male,Anthonie W A Lensing,Anthony K C Chan,Gili Kenet,Guy Young,Rukhmi Bhat,Akos F Pap,Dagmar Kubitza,Martin H Prins,Paul Monagle,
{"title":"Extended-phase anticoagulant treatment of acute venous thromboembolism in children: a cohort study from the EINSTEIN-Jr phase 3 trial.","authors":"Christoph Male,Anthonie W A Lensing,Anthony K C Chan,Gili Kenet,Guy Young,Rukhmi Bhat,Akos F Pap,Dagmar Kubitza,Martin H Prins,Paul Monagle,","doi":"10.1016/s2352-3026(25)00067-5","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00067-5","url":null,"abstract":"BACKGROUNDExtended-phase anticoagulation of venous thromboembolism in children is not well documented nor systematically reported. Previously, we reported on recurrent venous thromboembolism and bleeding during acute-phase anticoagulation in EINSTEIN-Jr, a randomised controlled study in 500 children with venous thromboembolism comparing rivaroxaban to standard anticoagulants. The aim of the present study was to evaluate the efficacy and safety of extended-phase anticoagulant therapy in children and to characterise factors associated with the decision to extend anticoagulation.METHODSChildren aged 17 years or younger, who were enrolled in the EINSTEIN-Jr trial (NCT02234843) from 107 paediatric hospitals in 28 countries, and who had previously completed a 3-month acute anticoagulation treatment phase (1-month in children <2 years with catheter-related venous thromboembolism) for acute venous thromboembolism within the trial were included in this cohort study. After completion of the preceding acute anticoagulation treatment phase, children could extend study treatment for up to 9 months (or up to 2 months for children <2 years with catheter-related venous thromboembolism). Study anticoagulants were bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20 mg equivalent dose or standard anticoagulants (heparin or vitamin K antagonist). The main outcomes were suspected recurrent venous thromboembolism (primary efficacy outcome) and clinically relevant bleeding (principal safety outcome), both confirmed or refuted by appropriate objective testing. Cumulative incidences of efficacy and safety outcomes are reported for children who received extended anticoagulation within the framework of the study. We also compared demographic and clinical characteristics of those administered any extended-phase anticoagulation (whether within or outside the framework of the study) with those not administered extended-phase anticoagulation, applying multivariable logistic regression.FINDINGS248 (51%) children received extended-phase anticoagulation between Nov 14, 2014, and Jan 15, 2019, 214 within the study and 34 outside the framework of the study. During extended-phase anticoagulant treatment, recurrent venous thromboembolism occurred in three (1%) of the 214 children within the study (cumulative incidence 3·0%; 95% CI 0·9-9·8). Clinically relevant non-major bleeding occurred in four (2%) of 214 children (3·3%; 1·2-9·2). Fatal venous thromboembolism or major bleeding did not occur. Outcome rates were similar with rivaroxaban or standard anticoagulants. Symptomatic index venous thromboembolism (odds ratio 1·88; 95% CI 1·14-3·11), unprovoked venous thromboembolism or persistent risk factor (2·16; 1·46-3·19), and residual thrombosis on repeat imaging (3·79; 2·52-5·71) were associated with the decision to extend anticoagulation.INTERPRETATIONIncidences of recurrent venous thromboembolism and bleeding during extended-phase anticoagulant treatment were low and simil","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"60 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143831561","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 it time for a large trial to evaluate aspirin for obstetric venous thromboembolism prophylaxis?","authors":"Alexander M Friedman","doi":"10.1016/s2352-3026(24)00374-0","DOIUrl":"https://doi.org/10.1016/s2352-3026(24)00374-0","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142991716","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}
Leslie Skeith,A Kinga Malinowski,Darine El-Chaâr,Wee-Shian Chan,Jennifer Donnelly,Céline Chauleur,Wessel Ganzevoort,Stephen Wood,Suzanne Dubois,Claire McCarthy,Andrea Buchmuller,Hanke Wiegers,Paul S Gibson,Fionnuala Ní Áinle,Saskia Middeldorp,Lisa Duffett,Shannon M Bates,Alexandra Garven,Jill Baxter,Brendan Cord Lethebe,Marc A Rodger,
{"title":"Low-dose aspirin versus placebo in postpartum venous thromboembolism: a multi-national, pilot, randomised, placebo-controlled trial.","authors":"Leslie Skeith,A Kinga Malinowski,Darine El-Chaâr,Wee-Shian Chan,Jennifer Donnelly,Céline Chauleur,Wessel Ganzevoort,Stephen Wood,Suzanne Dubois,Claire McCarthy,Andrea Buchmuller,Hanke Wiegers,Paul S Gibson,Fionnuala Ní Áinle,Saskia Middeldorp,Lisa Duffett,Shannon M Bates,Alexandra Garven,Jill Baxter,Brendan Cord Lethebe,Marc A Rodger,","doi":"10.1016/s2352-3026(24)00338-7","DOIUrl":"https://doi.org/10.1016/s2352-3026(24)00338-7","url":null,"abstract":"BACKGROUNDDespite the morbidity and mortality of venous thromboembolism, there is little evidence to guide postpartum thromboprophylaxis in patients at moderate risk. We aimed to assess the feasibility of conducting a double-blind, randomised trial of aspirin versus placebo in postpartum individuals with two or more venous thromboembolism risk factors, mild-to-moderate thrombophilia, or both.METHODSThe pilot PARTUM trial, a multi-national, randomised, double-blind, placebo-controlled trial, was conducted in seven centres across Canada, France, Ireland, and the Netherlands. Postpartum individuals aged 18 years or older with venous thromboembolism risk factors, including mild-moderate inherited thrombophilia, antepartum immobilisation, pre-pregnancy BMI of 30 kg/m2 or higher, pre-pregnancy smoking, previous superficial vein thrombosis, and other pregnancy-related conditions, were eligible. Participants were randomly assigned (1:1) within 48 h of delivery to aspirin 81 mg (80 mg in Europe) orally daily (low-dose aspirin group) or placebo orally once daily (placebo group) for 42 days. Follow-up visits occurred at 6 weeks and 90 days postpartum. The primary outcome was the mean recruitment rate (participants per site per month). Additional feasibility metrics were reported, and clinical outcomes were analysed by intention to treat. This study is registered with ClinicalTrials.gov, NCT04153760, and EudraCT, 2020-000619-58, and is completed.FINDINGSBetween Nov 2, 2020, and June 19, 2023, 10 040 patients were assessed for eligibility and 808 met all eligibility criteria, of whom 257 (32%) provided consent and were enrolled. 127 were randomly assigned to the low-dose aspirin group and 130 to the placebo group. The median follow-up was 91 days (IQR 89-96). The median age was 34·0 years (IQR 30·0-37·0), and 161 (63%) of participants were White. The mean recruitment rate was 6·3 (95% CI 5·5 to 7·2) patients per site per month. No venous thromboembolism events occurred in the low-dose aspirin group, and one participant had distal deep vein thrombosis in the placebo group (-0·82 [95% CI -2·42 to 0·78]). No major bleeds occurred. Three (2%) participants in the low-dose aspirin group versus one (1%) in the placebo group had clinically relevant non-major bleeds (absolute risk difference 1·66 [95% CI -1·54 to 4·86]). Ten serious adverse events occurred in nine (4%) of 257 participants, and 11 serious adverse events occurred in ten (4%) of 271 infants of participants. No treatment-related death occurred.INTERPRETATIONA global postpartum thromboprophylaxis trial evaluating low-dose aspirin is possible and needed to provide high-quality data.FUNDINGCanadian Institutes of Health Research and the INVENT-VTE Network.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"121 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142991714","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}