{"entity":{"id":"gallium","kind":"trial","name":"GALLIUM","aka":["BO21223"],"tldr":"GALLIUM showed that the newer anti-CD20 antibody obinutuzumab kept follicular lymphoma at bay for longer than rituximab when given with chemotherapy and as maintenance, at the cost of more serious side effects, and it became a first-line option.","summary":"GALLIUM was an open-label phase 3 trial in 1,401 patients with previously untreated advanced indolent non-Hodgkin lymphoma, 1,202 of them with follicular lymphoma, randomised to obinutuzumab or rituximab with bendamustine, CHOP or CVP chosen by the centre, followed by antibody maintenance for two years in responders. The primary endpoint was investigator-assessed progression-free survival in the follicular lymphoma population.\n\nAt a planned interim analysis with a median follow-up of 34.5 months, obinutuzumab reduced the risk of progression, relapse or death by a third (three-year progression-free survival 80.0 against 73.3 percent). Response rates were similar, but grade 3 to 5 adverse events (74.6 against 67.8 percent) and serious adverse events were more frequent with obinutuzumab. The result led to approval of obinutuzumab for untreated follicular lymphoma in 2017, and the corpus's follicular lymphoma page lists bendamustine-obinutuzumab alongside bendamustine-rituximab on this trial.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01332968","url":"https://clinicaltrials.gov/study/NCT01332968"}],"tags":["soc-trials"],"related":[],"cancers":["follicular-lymphoma","marginal-zone-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["obinutuzumab","rituximab","bendamustine","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gallium-obinutuzumab-first-line-follicular-lymphoma-marcus-nejm-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01332968","phase":"3","setting":"Previously untreated advanced indolent non-Hodgkin lymphoma, mainly follicular lymphoma: obinutuzumab or rituximab with the investigator's chemotherapy (bendamustine, CHOP or CVP), followed by two years of maintenance with the same antibody","sponsor":"Hoffmann-La Roche","result":"Three-year progression-free survival 80.0 percent with obinutuzumab-chemotherapy against 73.3 percent with rituximab-chemotherapy (hazard ratio 0.66, p 0.001); more grade 3 to 5 adverse events with obinutuzumab.","yearReported":2017,"enrolled":1401,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival at 3 years, follicular lymphoma (investigator-assessed)","primary":true,"unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy, then obinutuzumab maintenance","n":601,"value":80,"note":"Median follow-up 34.5 months"},{"name":"Rituximab + chemotherapy, then rituximab maintenance","n":601,"value":73.3}],"hr":0.66,"ci":[0.51,0.85],"p":"0.001","source":"https://doi.org/10.1056/NEJMoa1614598"},{"endpoint":"Patients with a progression-free survival event, follicular lymphoma (registry results)","unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy","value":16.8},{"name":"Rituximab + chemotherapy","value":24}],"hr":0.66,"ci":[0.51,0.85],"p":"0.0012","source":"https://clinicaltrials.gov/study/NCT01332968?tab=results"},{"endpoint":"Overall response rate","unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy","n":601,"value":88.5},{"name":"Rituximab + chemotherapy","n":601,"value":86.9}],"source":"https://doi.org/10.1056/NEJMoa1614598"},{"endpoint":"Grade 3 to 5 adverse events","unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy","value":74.6},{"name":"Rituximab + chemotherapy","value":67.8}],"source":"https://doi.org/10.1056/NEJMoa1614598"},{"endpoint":"Infusion-related events attributed to the antibody","unit":"%","arms":[{"name":"Obinutuzumab + chemotherapy","n":595,"value":59.3},{"name":"Rituximab + chemotherapy","n":597,"value":48.9}],"source":"https://doi.org/10.1056/NEJMoa1614598"}]},"route":"/trials/gallium/","neighbours":{"cancer":[{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-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/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"bendamustine","kind":"drug","name":"Bendamustine","route":"/drugs/bendamustine/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"obinutuzumab","kind":"drug","name":"Obinutuzumab","route":"/drugs/obinutuzumab/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"paper":[{"id":"paper-gallium-obinutuzumab-first-line-follicular-lymphoma-marcus-nejm-2017","kind":"paper","name":"GALLIUM: obinutuzumab for the first-line treatment of follicular lymphoma","route":"/key-papers/paper-gallium-obinutuzumab-first-line-follicular-lymphoma-marcus-nejm-2017/"}]}}