Pub Date : 2025-03-01Epub Date: 2025-02-04DOI: 10.1016/S2352-3026(24)00372-7
Sijian Yu, Fen Huang, Na Xu, Zhongming Zhang, Can Liu, Xiaojun Xu, Zhiping Fan, Xiangzong Zeng, Qiong Liu, Guo Qiu, Xu Xi, Ren Lin, Xinquan Liang, Yirong Jiang, Min Dai, Hua Jin, Xiaofang Li, Shunqing Wang, Meiqing Wu, Jing Sun, Li Xuan, Qifa Liu
<p><strong>Background: </strong>Retrospective studies suggested that haploidentical transplantation combined with unrelated cord blood might improve survival for patients with haematological malignancies. We aimed to assess whether transplantation of haploidentical peripheral blood stem cells (PBSCs) plus unrelated cord blood would achieve superior disease-free survival compared with transplantation of haploidentical PBSCs plus bone marrow in this population.</p><p><strong>Methods: </strong>We did an open-label, randomised, phase 3 trial at seven hospitals in China. Eligible patients (aged 18-65 years) had a diagnosis of haematological malignancy, an Eastern Cooperative Oncology Group performance status of 0-2 and transplant comorbidity index of 0-2, and were receiving their first allogenic haematopoietic stem cell transplant. Patients were randomly assigned (1:1) to receive transplantation of haploidentical PBSCs plus bone marrow or haploidentical PBSCs plus unrelated cord blood. The primary endpoint was 1-year disease-free survival. All efficacy and safety endpoints were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT05290545) and is complete.</p><p><strong>Findings: </strong>Between March 5, 2022, and Jan 2, 2023, 357 participants were screened for eligibility, and 314 were randomly assigned to receive transplantation of haploidentical PBSCs plus unrelated cord blood (n=157) or haploidentical PBSCs plus bone marrow (n=157). Median follow-up was 17·2 months (IQR 10·0-20·8) after random assignment. 1-year disease-free survival was 82·2% (95% CI 75·2-87·3) in the group receiving haploidentical PBSCs plus unrelated cord blood (PBSCs plus unrelated cord blood group) and 65·6% (57·6-72·5) in the group receiving haploidentical PBSCs plus bone marrow ([PBSCs plus bone marrow group] hazard ratio [HR] 0·47, 95% CI 0·30-0·74; p=0·0010). The most common grade 3-5 adverse events within 100 days of transplantation in participants in the PBSCs plus unrelated cord blood and PBSCs plus bone marrow groups were infections (58 [37%] of 157 vs 77 [49%] of 157, p=0·030), acute graft-versus-host disease (49 [31%] vs 61 [39%]), and gastrointestinal disorders (38 [24%] vs 38 [24%]). Seven (4%) patients in the PBSCs plus unrelated cord blood group and 17 (11%) in the PBSCs plus bone marrow group died of transplantation-related causes within 100 days of transplantation. Causes of deaths in the PBSCs plus unrelated cord blood group versus the PBSCs plus bone marrow group included infections (four [3%] vs 11 [7%]), acute graft-versus-host disease (one [1%] vs three [2%]), vascular disorders (two [1%] vs one [1%]), cardiac disorders (none vs one [1%]), and respiratory disorders (none vs one [1%]).</p><p><strong>Interpretation: </strong>Transplantation of haploidentical PBSCs plus unrelated cord blood achieved superior 1-year disease-free survival compared with transplantation of haploidentical PBSCs plus bone marrow in p
{"title":"Haploidentical peripheral blood stem cells combined with bone marrow or unrelated cord blood as grafts for haematological malignancies: an open-label, multicentre, randomised, phase 3 trial.","authors":"Sijian Yu, Fen Huang, Na Xu, Zhongming Zhang, Can Liu, Xiaojun Xu, Zhiping Fan, Xiangzong Zeng, Qiong Liu, Guo Qiu, Xu Xi, Ren Lin, Xinquan Liang, Yirong Jiang, Min Dai, Hua Jin, Xiaofang Li, Shunqing Wang, Meiqing Wu, Jing Sun, Li Xuan, Qifa Liu","doi":"10.1016/S2352-3026(24)00372-7","DOIUrl":"10.1016/S2352-3026(24)00372-7","url":null,"abstract":"<p><strong>Background: </strong>Retrospective studies suggested that haploidentical transplantation combined with unrelated cord blood might improve survival for patients with haematological malignancies. We aimed to assess whether transplantation of haploidentical peripheral blood stem cells (PBSCs) plus unrelated cord blood would achieve superior disease-free survival compared with transplantation of haploidentical PBSCs plus bone marrow in this population.</p><p><strong>Methods: </strong>We did an open-label, randomised, phase 3 trial at seven hospitals in China. Eligible patients (aged 18-65 years) had a diagnosis of haematological malignancy, an Eastern Cooperative Oncology Group performance status of 0-2 and transplant comorbidity index of 0-2, and were receiving their first allogenic haematopoietic stem cell transplant. Patients were randomly assigned (1:1) to receive transplantation of haploidentical PBSCs plus bone marrow or haploidentical PBSCs plus unrelated cord blood. The primary endpoint was 1-year disease-free survival. All efficacy and safety endpoints were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT05290545) and is complete.</p><p><strong>Findings: </strong>Between March 5, 2022, and Jan 2, 2023, 357 participants were screened for eligibility, and 314 were randomly assigned to receive transplantation of haploidentical PBSCs plus unrelated cord blood (n=157) or haploidentical PBSCs plus bone marrow (n=157). Median follow-up was 17·2 months (IQR 10·0-20·8) after random assignment. 1-year disease-free survival was 82·2% (95% CI 75·2-87·3) in the group receiving haploidentical PBSCs plus unrelated cord blood (PBSCs plus unrelated cord blood group) and 65·6% (57·6-72·5) in the group receiving haploidentical PBSCs plus bone marrow ([PBSCs plus bone marrow group] hazard ratio [HR] 0·47, 95% CI 0·30-0·74; p=0·0010). The most common grade 3-5 adverse events within 100 days of transplantation in participants in the PBSCs plus unrelated cord blood and PBSCs plus bone marrow groups were infections (58 [37%] of 157 vs 77 [49%] of 157, p=0·030), acute graft-versus-host disease (49 [31%] vs 61 [39%]), and gastrointestinal disorders (38 [24%] vs 38 [24%]). Seven (4%) patients in the PBSCs plus unrelated cord blood group and 17 (11%) in the PBSCs plus bone marrow group died of transplantation-related causes within 100 days of transplantation. Causes of deaths in the PBSCs plus unrelated cord blood group versus the PBSCs plus bone marrow group included infections (four [3%] vs 11 [7%]), acute graft-versus-host disease (one [1%] vs three [2%]), vascular disorders (two [1%] vs one [1%]), cardiac disorders (none vs one [1%]), and respiratory disorders (none vs one [1%]).</p><p><strong>Interpretation: </strong>Transplantation of haploidentical PBSCs plus unrelated cord blood achieved superior 1-year disease-free survival compared with transplantation of haploidentical PBSCs plus bone marrow in p","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":" ","pages":"e190-e200"},"PeriodicalIF":15.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143371178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01DOI: 10.1016/S2352-3026(25)00043-2
Maayan Leroy-Melamed, Teonna Wolford, Sona Smith, Victoria Adewale, Maya Bloomberg, Allison McGirr-Crowley, Patrick T McGann
{"title":"Reproductive justice and sickle cell disease: a call for a whole-person approach to care.","authors":"Maayan Leroy-Melamed, Teonna Wolford, Sona Smith, Victoria Adewale, Maya Bloomberg, Allison McGirr-Crowley, Patrick T McGann","doi":"10.1016/S2352-3026(25)00043-2","DOIUrl":"10.1016/S2352-3026(25)00043-2","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 3","pages":"e176-e177"},"PeriodicalIF":15.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01DOI: 10.1016/S2352-3026(25)00044-4
The Lancet Haematology Editors
{"title":"A thank you to our 2024 reviewers and update on inclusion and diversity commitments.","authors":"The Lancet Haematology Editors","doi":"10.1016/S2352-3026(25)00044-4","DOIUrl":"https://doi.org/10.1016/S2352-3026(25)00044-4","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 3","pages":"e171-e174"},"PeriodicalIF":15.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01Epub Date: 2025-02-10DOI: 10.1016/S2352-3026(25)00003-1
Khaled M Musallam
{"title":"What we now BELIEVE is achievable with luspatercept in transfusion-dependent β-thalassaemia.","authors":"Khaled M Musallam","doi":"10.1016/S2352-3026(25)00003-1","DOIUrl":"10.1016/S2352-3026(25)00003-1","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":" ","pages":"e164-e165"},"PeriodicalIF":15.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143415915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01DOI: 10.1016/S2352-3026(25)00001-8
Laura Nayeli Tecayehuatl-Negrete, Ana Lilia Peralta-Amaro, Karla Alejandra Romero-Cuevas, José Emmanuel Zúñiga-Espinosa, Roberto Alfredo Ibarra-Ponce de León
{"title":"Multisystem lymphomatoid granulomatosis in an immunocompetent woman.","authors":"Laura Nayeli Tecayehuatl-Negrete, Ana Lilia Peralta-Amaro, Karla Alejandra Romero-Cuevas, José Emmanuel Zúñiga-Espinosa, Roberto Alfredo Ibarra-Ponce de León","doi":"10.1016/S2352-3026(25)00001-8","DOIUrl":"10.1016/S2352-3026(25)00001-8","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 3","pages":"e230"},"PeriodicalIF":15.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01DOI: 10.1016/S2352-3026(24)00357-0
Hélène Schoemans, Elke Stienissen, Kathy Goris, Susan K Stewart, Meredith Cowden, Kristina Arnahoutova, Steven Z Pavletic, Hildegard Greinix, Anna Barata, Lorna Warwick, Natacha Bolanos, Isabel Barbosa, Guy Bouguet, Isabelle Lhenry-Yvon, Riikka-Leena Manninen, Simona Pavukova, Guy Tavori, Marleen van Amerongen, Anita Lawitschka, Kirk R Schultz, Daniel Wolff, Anne Herrmann
Graft-versus-host disease (GVHD) is a complication of hematopoietic cell transplantation (HCT) that has a low chance of complete remission and a substantial effect on morbidity and mortality. To better understand how to improve the field of GVHD research, management, and care, the cGVHD Eurograft Initiative organised a European community advisory board of patient advocates, with the assistance of the Lymphoma Coalition, to identify unmet needs. We present the results of this project in this Viewpoint, which identify unmet GVHD needs from the patient advocates' perspectives and provide five key actionable themes to improve GVHD management and care. The identified themes were: the need for reliable and tailored information, increased patient empowerment, access to professional dedicated care, optimal emotional support, and attention to the financial implications of GVHD, with improved communication as an overarching theme. This first step in patient-centred research opens the way to future collaborative initiatives by merging stakeholder perspectives to strive for better care and outcomes after HCT by addressing the most pertinent patient needs.
{"title":"Ask, do not tell: consulting a patient advisory board to understand unmet needs of patients with GVHD in Europe.","authors":"Hélène Schoemans, Elke Stienissen, Kathy Goris, Susan K Stewart, Meredith Cowden, Kristina Arnahoutova, Steven Z Pavletic, Hildegard Greinix, Anna Barata, Lorna Warwick, Natacha Bolanos, Isabel Barbosa, Guy Bouguet, Isabelle Lhenry-Yvon, Riikka-Leena Manninen, Simona Pavukova, Guy Tavori, Marleen van Amerongen, Anita Lawitschka, Kirk R Schultz, Daniel Wolff, Anne Herrmann","doi":"10.1016/S2352-3026(24)00357-0","DOIUrl":"10.1016/S2352-3026(24)00357-0","url":null,"abstract":"<p><p>Graft-versus-host disease (GVHD) is a complication of hematopoietic cell transplantation (HCT) that has a low chance of complete remission and a substantial effect on morbidity and mortality. To better understand how to improve the field of GVHD research, management, and care, the cGVHD Eurograft Initiative organised a European community advisory board of patient advocates, with the assistance of the Lymphoma Coalition, to identify unmet needs. We present the results of this project in this Viewpoint, which identify unmet GVHD needs from the patient advocates' perspectives and provide five key actionable themes to improve GVHD management and care. The identified themes were: the need for reliable and tailored information, increased patient empowerment, access to professional dedicated care, optimal emotional support, and attention to the financial implications of GVHD, with improved communication as an overarching theme. This first step in patient-centred research opens the way to future collaborative initiatives by merging stakeholder perspectives to strive for better care and outcomes after HCT by addressing the most pertinent patient needs.</p>","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 3","pages":"e214-e223"},"PeriodicalIF":15.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01DOI: 10.1016/S2352-3026(25)00002-X
Benjamin Chin-Yee, Lucie Laplane, Pierre Sujobert
The growing use of measurable residual disease (MRD) assays across haematology-oncology creates an urgent need for clinicians and researchers to reflect on the biological and clinical rationale of this class of biomarkers. In this Viewpoint, we critically examine two premises behind MRD's use in haematology-oncology, focusing on its biological plausibility as a predictive biomarker and surrogate endpoint, and the evidence needed for it to influence decision making in haematological cancers. Examining these premises leads us to advocate for the establishment of more robust biological and clinical evidence to ensure the clinically useful and safe application of MRD. Although achieving the eradication of cancer cells in the form of undetectable MRD seems an attractive goal in haematology-oncology, we highlight the epistemic limitations of this biomarker and need for more clinical evidence to guide its effective use.
{"title":"Epistemic limitations of measurable residual disease in haematological malignancies.","authors":"Benjamin Chin-Yee, Lucie Laplane, Pierre Sujobert","doi":"10.1016/S2352-3026(25)00002-X","DOIUrl":"10.1016/S2352-3026(25)00002-X","url":null,"abstract":"<p><p>The growing use of measurable residual disease (MRD) assays across haematology-oncology creates an urgent need for clinicians and researchers to reflect on the biological and clinical rationale of this class of biomarkers. In this Viewpoint, we critically examine two premises behind MRD's use in haematology-oncology, focusing on its biological plausibility as a predictive biomarker and surrogate endpoint, and the evidence needed for it to influence decision making in haematological cancers. Examining these premises leads us to advocate for the establishment of more robust biological and clinical evidence to ensure the clinically useful and safe application of MRD. Although achieving the eradication of cancer cells in the form of undetectable MRD seems an attractive goal in haematology-oncology, we highlight the epistemic limitations of this biomarker and need for more clinical evidence to guide its effective use.</p>","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 3","pages":"e224-e229"},"PeriodicalIF":15.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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