Ofatumumab as part of reduced intensity conditioning in high risk B-cell lymphoma patients: final long-term analysis from a prospective multicenter Phase-II Trial
Curative potential of allogeneic transplantation (AlloSCT) in high-risk non-Hodgkin lymphoma (NHL) could be enhanced by the integration of Ofatumumab (OFA), a 2nd generation anti-CD20 moAb, due to an antitumor effect and a role over graft-versus-host disease (GVHD). In this phase II trial (NCT016133...
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| Veröffentlicht in: | Bone marrow transplantation (Basingstoke) 2024-03, Vol.59 (3), p.359-365 |
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| creator | Cabrero, Mónica López-Corral, Lucia Jarque, Isidro de la Cruz-Vicente, Fátima Pérez- López, Estefanía Valcárcel, David Sanz, Jaime Espigado, Ildefonso Ortí, Guillermo Martín- Calvo, Carmen de la Serna, Javier Caballero, Dolores |
| description | Curative potential of allogeneic transplantation (AlloSCT) in high-risk non-Hodgkin lymphoma (NHL) could be enhanced by the integration of Ofatumumab (OFA), a 2nd generation anti-CD20 moAb, due to an antitumor effect and a role over graft-versus-host disease (GVHD). In this phase II trial (NCT01613300), we investigated safety and effectiveness of OFA-based reduced intensity conditioning (RIC). High-risk B-cell NHL patients with chemorrefractory disease or post-autologous SCT relapse were eligible. OFA was added to a standard RIC regimen. Primary endpoint was grade 3-4 aGVHD rate, while secondary endpoints included CR and survival rates. Thirty-three patients were included (median age 51; diffuse large B-cell:68%, HLA-identical donor: 74%). No grade >2 OFA toxicity was observed. Acute GVHD affected 77% of patients (16% grade 3-4). Remarkably, GVHD achieved CR in 75% of patients after first-line treatment. Chronic GVHD, primarily mild or moderate, occurred in 54% of patients. NHL CR rate at day +100 was 81%. Relapses occurred in 7 patients after a median of 3 months. Causes of death were lymphoma progression (5), infections (10), and GVHD (2). At 24 months, progression-free and overall survival rates were 50.1 and 51.6% respectively. OFA-RIC regimen is safe and effective, though acute GVHD remains a significant complication. However, data suggest that OFA could mitigate its severity. |
| doi_str_mv | 10.1038/s41409-023-02171-5 |
| format | Article |
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In this phase II trial (NCT01613300), we investigated safety and effectiveness of OFA-based reduced intensity conditioning (RIC). High-risk B-cell NHL patients with chemorrefractory disease or post-autologous SCT relapse were eligible. OFA was added to a standard RIC regimen. Primary endpoint was grade 3-4 aGVHD rate, while secondary endpoints included CR and survival rates. Thirty-three patients were included (median age 51; diffuse large B-cell:68%, HLA-identical donor: 74%). No grade >2 OFA toxicity was observed. Acute GVHD affected 77% of patients (16% grade 3-4). Remarkably, GVHD achieved CR in 75% of patients after first-line treatment. Chronic GVHD, primarily mild or moderate, occurred in 54% of patients. NHL CR rate at day +100 was 81%. Relapses occurred in 7 patients after a median of 3 months. Causes of death were lymphoma progression (5), infections (10), and GVHD (2). At 24 months, progression-free and overall survival rates were 50.1 and 51.6% respectively. OFA-RIC regimen is safe and effective, though acute GVHD remains a significant complication. However, data suggest that OFA could mitigate its severity.</description><identifier>ISSN: 0268-3369</identifier><identifier>ISSN: 1476-5365</identifier><identifier>EISSN: 1476-5365</identifier><identifier>DOI: 10.1038/s41409-023-02171-5</identifier><identifier>PMID: 38167647</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/308/153 ; 692/308/2779/109/1941 ; Allografts ; Antibodies, Monoclonal, Humanized ; Anticancer properties ; Antitumor activity ; B-cell lymphoma ; CD20 antigen ; Cell Biology ; Conditioning ; Disease-Free Survival ; Graft versus host disease ; Graft vs Host Disease - etiology ; Graft-versus-host reaction ; Hematology ; Hematopoietic Stem Cell Transplantation ; Humans ; Internal Medicine ; Lymphocytes B ; Lymphoma ; Lymphoma, B-Cell - drug therapy ; Lymphoma, Non-Hodgkin - therapy ; Medicine ; Medicine & Public Health ; Middle Aged ; Neoplasm Recurrence, Local ; Non-Hodgkin's lymphoma ; Prospective Studies ; Public Health ; Risk ; Stem Cells ; Survival ; Toxicity ; Transplantation ; Transplantation Conditioning - adverse effects</subject><ispartof>Bone marrow transplantation (Basingstoke), 2024-03, Vol.59 (3), p.359-365</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Limited 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2023. The Author(s), under exclusive licence to Springer Nature Limited.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c326t-df90c2986eeef59fdbdee4cebf90d50f01c85faf25944017100141d061c2e43c3</cites><orcidid>0000-0001-7586-4792</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38167647$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cabrero, Mónica</creatorcontrib><creatorcontrib>López-Corral, Lucia</creatorcontrib><creatorcontrib>Jarque, Isidro</creatorcontrib><creatorcontrib>de la Cruz-Vicente, Fátima</creatorcontrib><creatorcontrib>Pérez- López, Estefanía</creatorcontrib><creatorcontrib>Valcárcel, David</creatorcontrib><creatorcontrib>Sanz, Jaime</creatorcontrib><creatorcontrib>Espigado, Ildefonso</creatorcontrib><creatorcontrib>Ortí, Guillermo</creatorcontrib><creatorcontrib>Martín- Calvo, Carmen</creatorcontrib><creatorcontrib>de la Serna, Javier</creatorcontrib><creatorcontrib>Caballero, Dolores</creatorcontrib><creatorcontrib>Grupo Español de Trasplante Hematopoyético (GETH) and Grupo Español de Linfomas y Trasplante Autólogo (GELTAMO)</creatorcontrib><creatorcontrib>Grupo Español de Trasplante Hematopoyético (GETH) and Grupo Español de Linfomas y Trasplante Autólogo (GELTAMO)</creatorcontrib><title>Ofatumumab as part of reduced intensity conditioning in high risk B-cell lymphoma patients: final long-term analysis from a prospective multicenter Phase-II Trial</title><title>Bone marrow transplantation (Basingstoke)</title><addtitle>Bone Marrow Transplant</addtitle><addtitle>Bone Marrow Transplant</addtitle><description>Curative potential of allogeneic transplantation (AlloSCT) in high-risk non-Hodgkin lymphoma (NHL) could be enhanced by the integration of Ofatumumab (OFA), a 2nd generation anti-CD20 moAb, due to an antitumor effect and a role over graft-versus-host disease (GVHD). In this phase II trial (NCT01613300), we investigated safety and effectiveness of OFA-based reduced intensity conditioning (RIC). High-risk B-cell NHL patients with chemorrefractory disease or post-autologous SCT relapse were eligible. OFA was added to a standard RIC regimen. Primary endpoint was grade 3-4 aGVHD rate, while secondary endpoints included CR and survival rates. Thirty-three patients were included (median age 51; diffuse large B-cell:68%, HLA-identical donor: 74%). No grade >2 OFA toxicity was observed. Acute GVHD affected 77% of patients (16% grade 3-4). Remarkably, GVHD achieved CR in 75% of patients after first-line treatment. Chronic GVHD, primarily mild or moderate, occurred in 54% of patients. NHL CR rate at day +100 was 81%. Relapses occurred in 7 patients after a median of 3 months. Causes of death were lymphoma progression (5), infections (10), and GVHD (2). At 24 months, progression-free and overall survival rates were 50.1 and 51.6% respectively. OFA-RIC regimen is safe and effective, though acute GVHD remains a significant complication. However, data suggest that OFA could mitigate its severity.</description><subject>692/308/153</subject><subject>692/308/2779/109/1941</subject><subject>Allografts</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Anticancer properties</subject><subject>Antitumor activity</subject><subject>B-cell lymphoma</subject><subject>CD20 antigen</subject><subject>Cell Biology</subject><subject>Conditioning</subject><subject>Disease-Free Survival</subject><subject>Graft versus host disease</subject><subject>Graft vs Host Disease - etiology</subject><subject>Graft-versus-host reaction</subject><subject>Hematology</subject><subject>Hematopoietic Stem Cell Transplantation</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Lymphocytes B</subject><subject>Lymphoma</subject><subject>Lymphoma, B-Cell - drug therapy</subject><subject>Lymphoma, Non-Hodgkin - therapy</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local</subject><subject>Non-Hodgkin's lymphoma</subject><subject>Prospective Studies</subject><subject>Public Health</subject><subject>Risk</subject><subject>Stem Cells</subject><subject>Survival</subject><subject>Toxicity</subject><subject>Transplantation</subject><subject>Transplantation Conditioning - 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In this phase II trial (NCT01613300), we investigated safety and effectiveness of OFA-based reduced intensity conditioning (RIC). High-risk B-cell NHL patients with chemorrefractory disease or post-autologous SCT relapse were eligible. OFA was added to a standard RIC regimen. Primary endpoint was grade 3-4 aGVHD rate, while secondary endpoints included CR and survival rates. Thirty-three patients were included (median age 51; diffuse large B-cell:68%, HLA-identical donor: 74%). No grade >2 OFA toxicity was observed. Acute GVHD affected 77% of patients (16% grade 3-4). Remarkably, GVHD achieved CR in 75% of patients after first-line treatment. Chronic GVHD, primarily mild or moderate, occurred in 54% of patients. NHL CR rate at day +100 was 81%. Relapses occurred in 7 patients after a median of 3 months. Causes of death were lymphoma progression (5), infections (10), and GVHD (2). At 24 months, progression-free and overall survival rates were 50.1 and 51.6% respectively. OFA-RIC regimen is safe and effective, though acute GVHD remains a significant complication. However, data suggest that OFA could mitigate its severity.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>38167647</pmid><doi>10.1038/s41409-023-02171-5</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-7586-4792</orcidid></addata></record> |
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| ispartof | Bone marrow transplantation (Basingstoke), 2024-03, Vol.59 (3), p.359-365 |
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| subjects | 692/308/153 692/308/2779/109/1941 Allografts Antibodies, Monoclonal, Humanized Anticancer properties Antitumor activity B-cell lymphoma CD20 antigen Cell Biology Conditioning Disease-Free Survival Graft versus host disease Graft vs Host Disease - etiology Graft-versus-host reaction Hematology Hematopoietic Stem Cell Transplantation Humans Internal Medicine Lymphocytes B Lymphoma Lymphoma, B-Cell - drug therapy Lymphoma, Non-Hodgkin - therapy Medicine Medicine & Public Health Middle Aged Neoplasm Recurrence, Local Non-Hodgkin's lymphoma Prospective Studies Public Health Risk Stem Cells Survival Toxicity Transplantation Transplantation Conditioning - adverse effects |
| title | Ofatumumab as part of reduced intensity conditioning in high risk B-cell lymphoma patients: final long-term analysis from a prospective multicenter Phase-II Trial |
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