{"entity":{"id":"mogamulizumab-atll-0761-009","kind":"trial","name":"Study 0761-009: mogamulizumab against investigator's choice in relapsed adult T-cell leukaemia/lymphoma","aka":["0761-009","Phillips 2019"],"tldr":"Outside Japan, mogamulizumab produced confirmed responses in about one in ten people with relapsed adult T-cell leukaemia, more than chemotherapy did but far fewer than the Japanese study had suggested.","summary":"A randomised trial of mogamulizumab in adult T-cell leukaemia/lymphoma outside Japan, in patients of Caribbean, African and Latin American origin treated in the United States, Europe and Latin America. Patients with relapsed or refractory aggressive disease, stratified by subtype, were randomised 2:1 to mogamulizumab 1.0 mg/kg weekly for four weeks and then every two weeks (47 patients) or to the investigator's choice of chemotherapy (24). The primary endpoint was overall response confirmed on a second assessment eight weeks later by blinded independent review.\n\nConfirmed overall response was 11 per cent (95 per cent confidence interval 4 to 23) with mogamulizumab and 0 per cent (0 to 14) with chemotherapy; best response was 28 and 8 per cent. The hazard ratio for progression-free survival was 0.71 (0.41 to 1.21), and 0.57 (0.337 to 0.983) after a post hoc adjustment for an imbalance in performance status. The commonest grade 3 or worse treatment-related adverse events with mogamulizumab were infusion-related reaction and thrombocytopenia, 9 per cent each.","status":"mixed","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov NCT01626664","url":"https://clinicaltrials.gov/study/NCT01626664"},{"label":"Haematologica 2019","url":"https://doi.org/10.3324/haematol.2018.205096"}],"tags":["lymphoma-evidence-entities"],"related":[],"cancers":["adult-t-cell-leukaemia-lymphoma","peripheral-t-cell-lymphoma"],"sections":["immunotherapy"],"technologies":["monoclonal-antibody"],"targets":["ccr4"],"drugs":["mogamulizumab"],"companies":["kyowa-kirin"],"institutions":[],"pathways":[],"terms":["orr","lymphoma-htlv-1"],"trials":["mogamulizumab-atll-phase-2-japan"],"people":[],"bottlenecks":[],"keyPapers":["paper-mogamulizumab-vs-investigator-choice-atll-haematologica-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01626664","phase":"2","setting":"Relapsed or refractory aggressive adult T-cell leukaemia/lymphoma (acute, lymphoma and chronic types) in the United States, Europe and Latin America: mogamulizumab against investigator's choice of chemotherapy, randomised 2:1","sponsor":"Kyowa Kirin, Inc.","result":"Confirmed overall response 11 per cent with mogamulizumab against 0 per cent with chemotherapy; progression-free survival hazard ratio 0.71 (0.57 after a post hoc adjustment).","started":"2012-06","yearReported":2019,"enrolled":71,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed overall response rate (blinded independent review)","primary":true,"unit":"%","arms":[{"name":"Mogamulizumab","n":47,"value":11,"note":"95 per cent confidence interval 4 to 23"},{"name":"Investigator's choice of chemotherapy","n":24,"value":0,"note":"95 per cent confidence interval 0 to 14"}],"source":"https://doi.org/10.3324/haematol.2018.205096"},{"endpoint":"Progression-free survival","arms":[{"name":"Mogamulizumab","n":47},{"name":"Investigator's choice of chemotherapy","n":24}],"hr":0.71,"ci":[0.41,1.21],"source":"https://doi.org/10.3324/haematol.2018.205096"}],"replication":"Its response rate is well below the 50 per cent of the earlier Japanese single-arm study; the two populations differed in origin, subtype mix and prior treatment."},"route":"/trials/mogamulizumab-atll-0761-009/","neighbours":{"cancer":[{"id":"adult-t-cell-leukaemia-lymphoma","kind":"cancer","name":"Adult T-cell leukaemia/lymphoma","route":"/cancers/adult-t-cell-leukaemia-lymphoma/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"}],"section":[{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"ccr4","kind":"target","name":"CCR4","route":"/targets/ccr4/"}],"drug":[{"id":"mogamulizumab","kind":"drug","name":"Mogamulizumab","route":"/drugs/mogamulizumab/"}],"company":[{"id":"kyowa-kirin","kind":"company","name":"Kyowa Kirin","route":"/companies/kyowa-kirin/"}],"term":[{"id":"lymphoma-htlv-1","kind":"term","name":"HTLV-1 (human T-lymphotropic virus type 1)","route":"/terms/lymphoma-htlv-1/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"}],"trial":[{"id":"mogamulizumab-atll-phase-2-japan","kind":"trial","name":"Mogamulizumab phase 2 in relapsed adult T-cell leukaemia/lymphoma (Japan)","route":"/trials/mogamulizumab-atll-phase-2-japan/"}],"paper":[{"id":"paper-mogamulizumab-vs-investigator-choice-atll-haematologica-2019","kind":"paper","name":"Mogamulizumab versus investigator's choice of chemotherapy regimen in relapsed/refractory adult T-cell leukemia/lymphoma","route":"/key-papers/paper-mogamulizumab-vs-investigator-choice-atll-haematologica-2019/"}]}}