{"entity":{"id":"ielsg-19","kind":"trial","name":"IELSG-19","aka":["IELSG19","Chlorambucil versus rituximab versus both in MALT lymphoma"],"tldr":"The first randomised trial of first-line drug treatment for MALT lymphoma found that combining an old tablet with an antibody delayed relapse better than either alone, without anyone living longer.","summary":"Mucosa-associated lymphoid tissue lymphoma is common enough to matter and rare enough that nobody had randomised its systemic treatment. IELSG-19 did. The first 252 patients were randomised between chlorambucil alone and chlorambucil with rituximab; the protocol was then amended to a three-arm design adding rituximab alone, to a final 454 patients.\n\nAt a median follow-up of 7.4 years, five-year event-free survival was 51 per cent (95 per cent confidence interval 42 to 60) with chlorambucil alone, 50 per cent (42 to 59) with rituximab alone and 68 per cent (60 to 76) with the combination (p = 0.0009). The hazard ratio for the combination against chlorambucil alone was 0.54 (0.38 to 0.77). Progression-free survival also favoured the combination (p = 0.0119). Five-year overall survival was approximately 90 per cent in all three arms, and all treatments were well tolerated.\n\nThe practical reading: for MALT lymphoma that needs systemic treatment, the combination is the better choice if the aim is to stay in remission, and the near-identical survival across arms is a reminder that this disease rarely kills quickly. Most gastric cases never reach this trial at all, because eradicating Helicobacter pylori clears them.","status":"mixed","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT00210353","url":"https://clinicaltrials.gov/study/NCT00210353"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2016.70.6994"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["malt-lymphoma","marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":["immunotherapy","chemotherapy"],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":["chlorambucil","rituximab"],"companies":["ielsg"],"institutions":[],"pathways":[],"terms":["watchful-waiting"],"trials":[],"people":[],"bottlenecks":["b-rare-cancers","b-trial-enrolment"],"keyPapers":["paper-ielsg-19-chlorambucil-rituximab-malt-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00210353","phase":"3","setting":"Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue needing systemic treatment: chlorambucil, rituximab, or both","sponsor":"International Extranodal Lymphoma Study Group (IELSG)","result":"Five-year event-free survival 68 per cent with chlorambucil and rituximab against 51 and 50 per cent for either alone, with five-year overall survival about 90 per cent in all three arms.","started":"2003-01","yearReported":2017,"enrolled":454,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Chlorambucil with rituximab","value":68,"note":"95 per cent confidence interval 60 to 76"},{"name":"Chlorambucil alone","value":51,"note":"42 to 60"},{"name":"Rituximab alone","value":50,"note":"42 to 59"}],"hr":0.54,"ci":[0.38,0.77],"p":"0.0009","source":"https://doi.org/10.1200/JCO.2016.70.6994"}],"replication":"The only randomised first-line systemic trial in this disease."},"route":"/trials/ielsg-19/","neighbours":{"cancer":[{"id":"malt-lymphoma","kind":"cancer","name":"Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)","route":"/cancers/malt-lymphoma/"},{"id":"marginal-zone-lymphoma","kind":"cancer","name":"Marginal zone lymphoma","route":"/cancers/marginal-zone-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"chlorambucil","kind":"drug","name":"Chlorambucil","route":"/drugs/chlorambucil/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"}],"company":[{"id":"ielsg","kind":"company","name":"International Extranodal Lymphoma Study Group","route":"/companies/ielsg/"}],"term":[{"id":"watchful-waiting","kind":"term","name":"Watchful waiting, and how it differs from active surveillance","route":"/terms/watchful-waiting/"}],"bottleneck":[{"id":"b-rare-cancers","kind":"bottleneck","name":"Rare and paediatric cancers without markets","route":"/bottlenecks/b-rare-cancers/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}],"paper":[{"id":"paper-ielsg-19-chlorambucil-rituximab-malt-jco-2017","kind":"paper","name":"Final results of the IELSG-19 randomized trial of mucosa-associated lymphoid tissue lymphoma: improved event-free and progression-free survival with rituximab plus chlorambucil versus either chlorambucil or rituximab monotherapy","route":"/key-papers/paper-ielsg-19-chlorambucil-rituximab-malt-jco-2017/"}],"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/"}]}}