{"entity":{"id":"paper-lyma-rituximab-maintenance-after-transplant-mantle-cell-nejm-2017","kind":"paper","name":"Rituximab after autologous stem-cell transplantation in mantle-cell lymphoma","aka":["LyMa","Le Gouill 2017"],"tldr":"Three years of an antibody every two months after a stem cell transplant kept younger people with mantle cell lymphoma in remission longer and helped them live longer.","summary":"A phase 3 trial in 299 patients younger than 66 at diagnosis with mantle-cell lymphoma. After four courses of R-DHAP induction (rituximab, dexamethasone, high-dose cytarabine and a platinum derivative), the overall response rate was 89 per cent and the complete response rate 77 per cent. Transplantation was performed in 257 patients, and 240 were randomised 1 to 1 to rituximab 375 mg per square metre every two months for three years or to observation after transplantation; 59 patients did not undergo randomisation. The primary endpoint was event-free survival after transplantation among randomised patients, with an event defined as progression, relapse, death, allergy to rituximab or severe infection.\n\nAt a median follow-up of 50.2 months from randomisation (range 46.4 to 54.2), four-year event-free survival was 79 per cent (95 per cent confidence interval 70 to 86) with rituximab against 61 per cent (51 to 70) with observation (p = 0.001), and four-year progression-free survival 83 per cent (73 to 88) against 64 per cent (55 to 73). Overall survival was also prolonged.","asOf":"2026-10-01","links":[{"label":"New England Journal of Medicine 2017","url":"https://doi.org/10.1056/NEJMoa1701769"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/28953447/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/28953447"}],"tags":["lymphoma-evidence"],"related":["lymphoma-roadmap"],"cancers":["mantle-cell-lymphoma","non-hodgkin-lymphoma"],"sections":["immunotherapy","cell-therapy"],"technologies":[],"targets":["cd20","ccnd1"],"drugs":["rituximab","dexamethasone","cytarabine","cisplatin"],"companies":["lysa"],"institutions":[],"pathways":[],"terms":["maintenance-therapy","autologous-transplant","lymphoma-tx-transplant-role"],"trials":["lyma","triangle"],"people":["catherine-thieblemont"],"bottlenecks":["b-toxicity-qol"],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2017,"doi":"10.1056/NEJMoa1701769","pmid":"28953447","authors":"Le Gouill S, Thieblemont C, Oberic L, et al.","paperType":"rct","findings":["Four-year event-free survival was 79 per cent (95 per cent confidence interval 70 to 86) with rituximab maintenance against 61 per cent (51 to 70) with observation (p = 0.001).","Four-year progression-free survival was 83 per cent (73 to 88) against 64 per cent (55 to 73).","Rituximab maintenance prolonged overall survival as well as event-free and progression-free survival.","After four courses of R-DHAP induction the overall response rate was 89 per cent and the complete response rate 77 per cent.","Of 299 patients enrolled, 257 were transplanted and 240 were randomised."],"whatItMeans":"One of the few maintenance strategies in lymphoma that improved overall survival rather than only progression-free survival, and the reason three years of rituximab became standard after autologous transplantation in mantle cell lymphoma.","caveats":["The event-free survival definition included allergy to rituximab and severe infection as events, which cuts both ways in a trial of rituximab.","Restricted to patients under 66 fit enough for R-DHAP and autologous transplantation.","59 of 299 enrolled patients were never randomised, mostly because they did not reach transplantation.","TRIANGLE has since questioned whether the transplant itself is needed when ibrutinib is added, which changes the setting in which this result applies."],"changedPractice":true,"participants":240},"route":"/key-papers/paper-lyma-rituximab-maintenance-after-transplant-mantle-cell-nejm-2017/","neighbours":{"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"cancer":[{"id":"mantle-cell-lymphoma","kind":"cancer","name":"Mantle cell lymphoma","route":"/cancers/mantle-cell-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"section":[{"id":"cell-therapy","kind":"section","name":"Cell Therapy","route":"/fronts/cell-therapy/"},{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"target":[{"id":"ccnd1","kind":"target","name":"CCND1","route":"/targets/ccnd1/"},{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"cytarabine","kind":"drug","name":"Cytarabine","route":"/drugs/cytarabine/"},{"id":"dexamethasone","kind":"drug","name":"Dexamethasone","route":"/drugs/dexamethasone/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"}],"company":[{"id":"lysa","kind":"company","name":"LYSA (The Lymphoma Study Association)","route":"/companies/lysa/"}],"term":[{"id":"autologous-transplant","kind":"term","name":"Autologous stem cell transplant (ASCT)","route":"/terms/autologous-transplant/"},{"id":"maintenance-therapy","kind":"term","name":"Maintenance therapy","route":"/terms/maintenance-therapy/"},{"id":"lymphoma-tx-transplant-role","kind":"term","name":"Stem cell transplant in lymphoma: what it is still for","route":"/terms/lymphoma-tx-transplant-role/"}],"trial":[{"id":"lyma","kind":"trial","name":"LyMa","route":"/trials/lyma/"},{"id":"triangle","kind":"trial","name":"TRIANGLE","route":"/trials/triangle/"}],"person":[{"id":"catherine-thieblemont","kind":"person","name":"Catherine Thieblemont","route":"/people/catherine-thieblemont/"}],"bottleneck":[{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}],"paper":[{"id":"paper-triangle-ibrutinib-mantle-cell-lymphoma-dreyling-lancet-2024","kind":"paper","name":"TRIANGLE: ibrutinib with immunochemotherapy with or without autologous transplant versus immunochemotherapy and transplant in untreated mantle cell lymphoma","route":"/key-papers/paper-triangle-ibrutinib-mantle-cell-lymphoma-dreyling-lancet-2024/"}]}}