Pub Date : 2026-01-14DOI: 10.1016/s2352-3026(25)00323-0
Jonas S Heitmann,Yacine Maringer,Susanne Jung,Marcel Wacker,Christopher Hackenbruch,Mark Polster,Maddalena Marconato,Annika Nelde,Jens Bauer,Melissa Zwick,Anna-Sophia Baur,Ariane Lehmann,Christopher Krolla,Geoffroy Andrieux,Natalie Köhler,Melanie Boerries,Monika Denk,Lisa Zieschang,Christine Kammer,Naomi Hoenisch-Gravel,Marion Richter,Melek Tutku Oezbek,Stefan Wirths,Anna Dengler,Marissa L Dubbelaar,Marina Pumptow,Peter Martus,Monika Brüggemann,Hans-Georg Rammensee,Helmut R Salih,Juliane S Walz
BACKGROUNDTherapeutic T-cell activation to induce tumour-specific immune responses promises sustainable cancer control. However, this treatment is not yet widely used because of the challenges of personalised drug design and a shortage of mutation-derived neoepitopes. This study aimed to evaluate the immunogenicity, safety, and toxicity of iTAC-XS15-CLL01, a personalised warehouse-based multipeptide T-cell activator combined with the Toll-like receptor 1/2 ligand XS15, in patients with chronic lymphocytic leukaemia who were undergoing Bruton's tyrosine kinase inhibitor (BTKi)-based regimes.METHODSThis open-label, single-centre, phase 1 study, conducted in Germany, enrolled patients aged 18 years or older who had chronic lymphocytic leukaemia with an Eastern Cooperative Oncology Group score of 2 or lower and were due to receive a BTKi-based regimen either as monotherapy or in combination (eg, with anti-CD20). The patients' HLA allotype had to match at least one of the corresponding HLA alleles of peptides included in the peptide warehouse. To begin treatment with iTAC-XS15-CLL01, patients had to have reached at least partial remission with remaining minimal residual disease after 6-8 months of BTKi therapy. iTAC-XS15-CLL01 comprised eight chronic lymphocytic leukaemia-specific peptides, selected for the individual patient from a peptide warehouse on the basis of HLA allotyping and immunopeptidomics. Participants received three monthly doses of iTAC-XS15-CLL01 (consisting of 300 μg of each peptide plus 50 μg XS15, emulsified in Montanide ISA 51 VG), injected subcutaneously. The primary endpoints were induction of a T-cell response after application of iTAC-XS15-CLL01 compared with baseline, as assessed with IFNγ ELISpot assays, and the frequency and severity of adverse events from the first application of iTAC-XS15-CLL01 to end of treatment. All analyses were done per protocol. This study was registered with ClinicalTrials.gov (NCT04688385) and is now closed.FINDINGSBetween Jan 21, 2021, and July 7, 2023, 30 patients with chronic lymphocytic leukaemia were screened, and 20 were recruited to enter the iTAC-XS15-CLL01 treatment phase and followed up for 6 months. All patients were of White ethnicity; six (30%) patients were female, and 14 (70%) were male. Median age was 56·5 years (IQR 49·5-65·5). The most common grade 3 adverse events were injection-site erythema (three [15%] of 20 patients), granuloma (two [10%] of 20), and ulceration (one [5%] of 20). There were no grade 4 adverse events or treatment-related serious adverse events deaths. T-cell responses targeting multiple peptides were induced in 19 (95% [95% CI 75·1-99·9]) of 20 patients at end of treatment and persisted in 16 (84%) of 19 at 6 months follow-up, with the intensity of responses increasing until end of study.INTERPRETATIONOur findings indicate that iTAC-XS15-CLL01 could be a potent immunotherapeutic agent in patients with chronic lymphocytic leukaemia and should be further evaluat
治疗性t细胞激活诱导肿瘤特异性免疫反应有望实现可持续的癌症控制。然而，由于个性化药物设计的挑战和突变衍生的新表位的短缺，这种治疗尚未广泛应用。本研究旨在评估iTAC-XS15-CLL01的免疫原性、安全性和毒性，itac -XS15是一种个性化的基于仓库的多肽t细胞激活剂，结合toll样受体1/2配体XS15，用于接受布鲁顿酪氨酸激酶抑制剂（BTKi）的慢性淋巴细胞白血病患者。方法：这项开放标签、单中心、一期研究在德国进行，纳入了年龄在18岁或以上的慢性淋巴细胞白血病患者，东部肿瘤合作组评分为2分或更低，计划接受基于btki的单药治疗或联合治疗（例如，与抗cd20）。患者的HLA等位型必须与肽库中包含的肽的至少一个相应的HLA等位基因相匹配。要开始使用iTAC-XS15-CLL01治疗，患者必须在接受BTKi治疗6-8个月后达到至少部分缓解，并且剩余的残余疾病最小。iTAC-XS15-CLL01由8个慢性淋巴细胞白血病特异性肽组成，这些肽是根据HLA同种异体分型和免疫肽组学从肽库中为个体患者选择的。参与者接受三个月剂量的iTAC-XS15-CLL01皮下注射（每种肽300 μg加50 μg XS15，在Montanide ISA 51 VG中乳化）。主要终点是使用IFNγ ELISpot检测iTAC-XS15-CLL01与基线相比诱导t细胞反应，以及从首次使用iTAC-XS15-CLL01到治疗结束不良事件的频率和严重程度。所有分析均按方案完成。该研究已在ClinicalTrials.gov注册（NCT04688385），目前已结束。研究结果：在2021年1月21日至2023年7月7日期间，筛选了30例慢性淋巴细胞白血病患者，其中20例被招募进入iTAC-XS15-CLL01治疗期，随访6个月。所有患者均为白人；女性6例（30%），男性14例（70%）。中位年龄为56.5岁（IQR为49.5 ~ 65.5）。最常见的3级不良事件是注射部位红斑（20例患者中3例[15%]）、肉芽肿（20例患者中2例[10%]）和溃疡（20例患者中1例[5%]）。没有4级不良事件或与治疗相关的严重不良事件死亡。治疗结束时，20例患者中有19例（95% [95% CI 75.1 - 99.9]）患者产生了靶向多肽的t细胞反应，随访6个月时，19例患者中有16例（84%）患者持续产生t细胞反应，反应强度不断增强，直至研究结束。我们的研究结果表明，iTAC-XS15-CLL01可能是慢性淋巴细胞白血病患者的有效免疫治疗剂，应该在2期试验中进一步评估。资助：宾根大学医学院。
{"title":"Personalised multipeptide-based T-cell activator for chronic lymphocytic leukaemia: an open-label, single-centre, phase 1 study.","authors":"Jonas S Heitmann,Yacine Maringer,Susanne Jung,Marcel Wacker,Christopher Hackenbruch,Mark Polster,Maddalena Marconato,Annika Nelde,Jens Bauer,Melissa Zwick,Anna-Sophia Baur,Ariane Lehmann,Christopher Krolla,Geoffroy Andrieux,Natalie Köhler,Melanie Boerries,Monika Denk,Lisa Zieschang,Christine Kammer,Naomi Hoenisch-Gravel,Marion Richter,Melek Tutku Oezbek,Stefan Wirths,Anna Dengler,Marissa L Dubbelaar,Marina Pumptow,Peter Martus,Monika Brüggemann,Hans-Georg Rammensee,Helmut R Salih,Juliane S Walz","doi":"10.1016/s2352-3026(25)00323-0","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00323-0","url":null,"abstract":"BACKGROUNDTherapeutic T-cell activation to induce tumour-specific immune responses promises sustainable cancer control. However, this treatment is not yet widely used because of the challenges of personalised drug design and a shortage of mutation-derived neoepitopes. This study aimed to evaluate the immunogenicity, safety, and toxicity of iTAC-XS15-CLL01, a personalised warehouse-based multipeptide T-cell activator combined with the Toll-like receptor 1/2 ligand XS15, in patients with chronic lymphocytic leukaemia who were undergoing Bruton's tyrosine kinase inhibitor (BTKi)-based regimes.METHODSThis open-label, single-centre, phase 1 study, conducted in Germany, enrolled patients aged 18 years or older who had chronic lymphocytic leukaemia with an Eastern Cooperative Oncology Group score of 2 or lower and were due to receive a BTKi-based regimen either as monotherapy or in combination (eg, with anti-CD20). The patients' HLA allotype had to match at least one of the corresponding HLA alleles of peptides included in the peptide warehouse. To begin treatment with iTAC-XS15-CLL01, patients had to have reached at least partial remission with remaining minimal residual disease after 6-8 months of BTKi therapy. iTAC-XS15-CLL01 comprised eight chronic lymphocytic leukaemia-specific peptides, selected for the individual patient from a peptide warehouse on the basis of HLA allotyping and immunopeptidomics. Participants received three monthly doses of iTAC-XS15-CLL01 (consisting of 300 μg of each peptide plus 50 μg XS15, emulsified in Montanide ISA 51 VG), injected subcutaneously. The primary endpoints were induction of a T-cell response after application of iTAC-XS15-CLL01 compared with baseline, as assessed with IFNγ ELISpot assays, and the frequency and severity of adverse events from the first application of iTAC-XS15-CLL01 to end of treatment. All analyses were done per protocol. This study was registered with ClinicalTrials.gov (NCT04688385) and is now closed.FINDINGSBetween Jan 21, 2021, and July 7, 2023, 30 patients with chronic lymphocytic leukaemia were screened, and 20 were recruited to enter the iTAC-XS15-CLL01 treatment phase and followed up for 6 months. All patients were of White ethnicity; six (30%) patients were female, and 14 (70%) were male. Median age was 56·5 years (IQR 49·5-65·5). The most common grade 3 adverse events were injection-site erythema (three [15%] of 20 patients), granuloma (two [10%] of 20), and ulceration (one [5%] of 20). There were no grade 4 adverse events or treatment-related serious adverse events deaths. T-cell responses targeting multiple peptides were induced in 19 (95% [95% CI 75·1-99·9]) of 20 patients at end of treatment and persisted in 16 (84%) of 19 at 6 months follow-up, with the intensity of responses increasing until end of study.INTERPRETATIONOur findings indicate that iTAC-XS15-CLL01 could be a potent immunotherapeutic agent in patients with chronic lymphocytic leukaemia and should be further evaluat","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145993032","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}
Pub Date : 2025-12-22DOI: 10.1016/s2352-3026(25)00342-4
Reem Karmali, Leo I Gordon
{"title":"Sequencing T-cell therapy for relapsed or refractory large B-cell lymphoma","authors":"Reem Karmali, Leo I Gordon","doi":"10.1016/s2352-3026(25)00342-4","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00342-4","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"118 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145813912","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}
Pub Date : 2025-12-22DOI: 10.1016/s2352-3026(25)00318-7
Mark Sorin PhD, Rakan Okde MD, Merrik Goulet DEC, Louis Ghaleb BSc, Roger Pang DEC, Connor Prosty MD, Eugene Brailovski MD, Sarit Assouline MD
The optimal treatment sequence for large B-cell lymphoma is unknown. We aimed to assess through meta-analysis the comparative effectiveness of bispecific antibodies (BsAb) after chimeric antigen receptor T-cell therapy (CAR-T) or CAR-T after BsAb.
{"title":"Chimeric antigen receptor T-cell therapy and bispecific antibody sequence for large B-cell lymphoma: a systematic review and meta-analysis","authors":"Mark Sorin PhD, Rakan Okde MD, Merrik Goulet DEC, Louis Ghaleb BSc, Roger Pang DEC, Connor Prosty MD, Eugene Brailovski MD, Sarit Assouline MD","doi":"10.1016/s2352-3026(25)00318-7","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00318-7","url":null,"abstract":"The optimal treatment sequence for large B-cell lymphoma is unknown. We aimed to assess through meta-analysis the comparative effectiveness of bispecific antibodies (BsAb) after chimeric antigen receptor T-cell therapy (CAR-T) or CAR-T after BsAb.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145813968","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}
Pub Date : 2025-12-08DOI: 10.1016/s2352-3026(25)00327-8
Prof Arnon P Kater MD PhD, Ann Janssens MD, Herbert Eradat MD, Fritz Offner MD PhD, Jose D Sandoval-Sus MD, Mazyar Shadman MD MPH, Christian Bjørn Poulsen MD, Jacob Haaber Christensen MD PhD, Meghan C Thompson MD, Meijian Guan PhD, Andrew J Steele PhD, Marcia Rios MBA, Marie Holst Mørch MS, Toshihiko Oki MD PhD, Rebecca Valentin MD PhD, Mar Bellido MD PhD, Barbara Eichhorst MD
Richter transformation is one of the most challenging B-cell lymphomas to treat, particularly in patients with high-risk chronic lymphocytic leukaemia features or who have had previous therapy for chronic lymphocytic leukaemia. Median survival remains 6–12 months across various therapeutic approaches. We evaluated the safety and preliminary activity of epcoritamab monotherapy, a subcutaneous CD3×CD20 bispecific antibody, in patients with Richter transformation.
{"title":"Epcoritamab monotherapy for Richter transformation (EPCORE CLL-1): findings from a single-arm, multicentre, open-label, phase 1b/2 trial","authors":"Prof Arnon P Kater MD PhD, Ann Janssens MD, Herbert Eradat MD, Fritz Offner MD PhD, Jose D Sandoval-Sus MD, Mazyar Shadman MD MPH, Christian Bjørn Poulsen MD, Jacob Haaber Christensen MD PhD, Meghan C Thompson MD, Meijian Guan PhD, Andrew J Steele PhD, Marcia Rios MBA, Marie Holst Mørch MS, Toshihiko Oki MD PhD, Rebecca Valentin MD PhD, Mar Bellido MD PhD, Barbara Eichhorst MD","doi":"10.1016/s2352-3026(25)00327-8","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00327-8","url":null,"abstract":"Richter transformation is one of the most challenging B-cell lymphomas to treat, particularly in patients with high-risk chronic lymphocytic leukaemia features or who have had previous therapy for chronic lymphocytic leukaemia. Median survival remains 6–12 months across various therapeutic approaches. We evaluated the safety and preliminary activity of epcoritamab monotherapy, a subcutaneous CD3×CD20 bispecific antibody, in patients with Richter transformation.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145705013","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}
Pub Date : 2025-12-06DOI: 10.1016/s2352-3026(25)00291-1
Prof Isabelle Mahé MD PhD, Céline Chapelle, Philippe Girard MD, Marc Carrier MD, Luis Jara Palomares MD PhD, Prof Charles-Marc Samama MD PhD, Hélène Helfer PhD, Prof Grigoris Gerotziafas MD PhD, Prof Silvy Laporte PhD, Prof Eric Vicaut MD, Prof Patrick Mismetti MD PhD, API-CAT Study Group, Isabelle Mahé, Silvy Laporte, Didier Mayeur, Giancarlo Agnelli, Cecilia Becattini, Manuel Monreal, Juan José López-Núñez, Peter Verhamme, Adam Torbicki, Sebastian Szmit, Marc Righini, Alexander T Cohen, Anthony Maraveyas, Menno Huisman, Frederikus A Klok, Kostas N Syrigos, Aristotelis Bamias, Cihan Ay, Marc Carrier, Grégoire Le Gal, Eric Vicaut, API-CAT Investigators
Extended anticoagulation with reduced-dose apixaban was shown to be non-inferior to full-dose apixaban for preventing recurrent venous thromboembolism (VTE) in patients with active cancer and to be associated with fewer clinically relevant bleeding complications in a non-inferiority trial. In this post-hoc analysis, we sought to identify predictors associated with clinically relevant bleeding.
{"title":"Predictors of clinically relevant bleeding during extended anticoagulation for cancer-associated venous thromboembolism (API-CAT): a post-hoc analysis of a randomised, non-inferiority trial","authors":"Prof Isabelle Mahé MD PhD, Céline Chapelle, Philippe Girard MD, Marc Carrier MD, Luis Jara Palomares MD PhD, Prof Charles-Marc Samama MD PhD, Hélène Helfer PhD, Prof Grigoris Gerotziafas MD PhD, Prof Silvy Laporte PhD, Prof Eric Vicaut MD, Prof Patrick Mismetti MD PhD, API-CAT Study Group, Isabelle Mahé, Silvy Laporte, Didier Mayeur, Giancarlo Agnelli, Cecilia Becattini, Manuel Monreal, Juan José López-Núñez, Peter Verhamme, Adam Torbicki, Sebastian Szmit, Marc Righini, Alexander T Cohen, Anthony Maraveyas, Menno Huisman, Frederikus A Klok, Kostas N Syrigos, Aristotelis Bamias, Cihan Ay, Marc Carrier, Grégoire Le Gal, Eric Vicaut, API-CAT Investigators","doi":"10.1016/s2352-3026(25)00291-1","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00291-1","url":null,"abstract":"Extended anticoagulation with reduced-dose apixaban was shown to be non-inferior to full-dose apixaban for preventing recurrent venous thromboembolism (VTE) in patients with active cancer and to be associated with fewer clinically relevant bleeding complications in a non-inferiority trial. In this post-hoc analysis, we sought to identify predictors associated with clinically relevant bleeding.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145705015","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}
Pub Date : 2025-12-01DOI: 10.1016/s2352-3026(25)00295-9
Johnny Mahlangu,Raffaella Colombatti,John James,Cassandra Trimnell,John Waller,Samar Al-Behaisi,Adam Wufsus,Gareth Morrell,Biree Andemariam
BACKGROUNDLimited clinical trial awareness, inadequate funding and training of health-care professionals, and inequitable clinical trial participation opportunities hinder improvements in treatment outcomes for people with sickle cell disease. The aim of this study was to inform the design and delivery of future clinical trials to maximise patient recruitment and ensure that future clinical research delivers the best outcomes for the sickle cell disease community.METHODSThe LISTEN Survey comprised an online questionnaire available in 11 languages and adapted for digital, telephone, or paper completion depending on the region. People with sickle cell disease aged 18 years or older were recruited through patient organisations, health-care professionals, and agencies across 17 countries. Respondents rated and ranked the importance of factors influencing their decision to participate in a clinical trial. Responses were analysed descriptively, with missing data handled using predefined non-response options.FINDINGSBetween Oct 6, 2022 and Aug 22, 2023, 1145 people responded to the survey. Of these, 662 (58%) were female and 482 (42%) were male, and 307 (27%) were located in sub-Saharan African. 373 (33%) had been invited to participate in a clinical trial for sickle cell disease, with more limited participation in sub-Saharan Africa (48 [16%] of 307), the Middle East and North Africa (15 [11%] of 142), and India (0 of 78). Motivating factors rated as extremely or very important were the potential to better manage symptoms (573 [50%] of 1145), the opportunity to try a new treatment that might work better (572 [50%] of 1145), and increasing knowledge of sickle cell disease (574 [50%] of 1145). Regional ratings were similar or showed minor differences for questions on potential impact of participation on daily life, but differed for the impact of receiving trial treatment and wider trial impact. The potential for side-effects (587 [51%] of 1145) was an important barrier to clinical trial participation. The most important information people with sickle cell disease wanted to know included planned safety measures (643 [56%] of 1145) and how the treatment works (547 [48%] of 1145). The most important further considerations were the opportunity to speak with experts running the clinical trial (572 [50%] of 1145) and people with sickle cell disease already participating in the clinical trial (562 [49%] of 1145).INTERPRETATIONBalanced and tailored communication about clinical trials to the sickle cell disease community should be prioritised to optimise participation opportunities, thereby enhancing representation and generalisability of the results.FUNDINGNovo Nordisk Health Care (Zurich, Switzerland).
{"title":"Motivators and barriers affecting decisions to participate in sickle cell disease clinical trials in the global Learning and Insights into Sickle Cell Trial Experiences (LISTEN) Survey: global and regional findings.","authors":"Johnny Mahlangu,Raffaella Colombatti,John James,Cassandra Trimnell,John Waller,Samar Al-Behaisi,Adam Wufsus,Gareth Morrell,Biree Andemariam","doi":"10.1016/s2352-3026(25)00295-9","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00295-9","url":null,"abstract":"BACKGROUNDLimited clinical trial awareness, inadequate funding and training of health-care professionals, and inequitable clinical trial participation opportunities hinder improvements in treatment outcomes for people with sickle cell disease. The aim of this study was to inform the design and delivery of future clinical trials to maximise patient recruitment and ensure that future clinical research delivers the best outcomes for the sickle cell disease community.METHODSThe LISTEN Survey comprised an online questionnaire available in 11 languages and adapted for digital, telephone, or paper completion depending on the region. People with sickle cell disease aged 18 years or older were recruited through patient organisations, health-care professionals, and agencies across 17 countries. Respondents rated and ranked the importance of factors influencing their decision to participate in a clinical trial. Responses were analysed descriptively, with missing data handled using predefined non-response options.FINDINGSBetween Oct 6, 2022 and Aug 22, 2023, 1145 people responded to the survey. Of these, 662 (58%) were female and 482 (42%) were male, and 307 (27%) were located in sub-Saharan African. 373 (33%) had been invited to participate in a clinical trial for sickle cell disease, with more limited participation in sub-Saharan Africa (48 [16%] of 307), the Middle East and North Africa (15 [11%] of 142), and India (0 of 78). Motivating factors rated as extremely or very important were the potential to better manage symptoms (573 [50%] of 1145), the opportunity to try a new treatment that might work better (572 [50%] of 1145), and increasing knowledge of sickle cell disease (574 [50%] of 1145). Regional ratings were similar or showed minor differences for questions on potential impact of participation on daily life, but differed for the impact of receiving trial treatment and wider trial impact. The potential for side-effects (587 [51%] of 1145) was an important barrier to clinical trial participation. The most important information people with sickle cell disease wanted to know included planned safety measures (643 [56%] of 1145) and how the treatment works (547 [48%] of 1145). The most important further considerations were the opportunity to speak with experts running the clinical trial (572 [50%] of 1145) and people with sickle cell disease already participating in the clinical trial (562 [49%] of 1145).INTERPRETATIONBalanced and tailored communication about clinical trials to the sickle cell disease community should be prioritised to optimise participation opportunities, thereby enhancing representation and generalisability of the results.FUNDINGNovo Nordisk Health Care (Zurich, Switzerland).","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"25 1","pages":"e966-e977"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145664020","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}
Pub Date : 2025-12-01DOI: 10.1016/s2352-3026(25)00316-3
Jan Karregat,Amber Meulenbeld,Katja van den Hurk
{"title":"Ferritin-guided iron supplementation in blood donors - Authors' reply.","authors":"Jan Karregat,Amber Meulenbeld,Katja van den Hurk","doi":"10.1016/s2352-3026(25)00316-3","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00316-3","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"113 1","pages":"e928-e929"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145664031","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":"Illegal blood trade as cause for blood shortages in public hospitals in northern Nigeria.","authors":"Halima Ismail,Yahya Yazid Ibrahim,Dalhat Halliru Gwarzo,Aisha Kuliya-Gwarzo,Kerstin Weitmann,Sophie Reichelt,Kathleen Selleng,Andreas Greinacher","doi":"10.1016/s2352-3026(25)00296-0","DOIUrl":"https://doi.org/10.1016/s2352-3026(25)00296-0","url":null,"abstract":"","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"33 1","pages":"e933-e934"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145664025","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}
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