{"entity":{"id":"mlsg15-mogamulizumab-atll","kind":"trial","name":"mLSG15 with or without mogamulizumab","aka":["mLSG15 plus KW-0761","Ishida 2015"],"tldr":"Adding mogamulizumab to the intensive Japanese chemotherapy for newly diagnosed adult T-cell leukaemia raised the complete remission rate, at the cost of more side effects, including infections and lung inflammation.","summary":"A randomised phase 2 study in Japan asking whether mogamulizumab adds to mLSG15, the dose-intensified VCAP-AMP-VECP chemotherapy that JCOG9801 made the Japanese standard, in newly diagnosed aggressive adult T-cell leukaemia/lymphoma. Patients were assigned 1:1; the primary endpoint was the complete response rate.\n\nComplete response was 52 per cent (95 per cent confidence interval 33 to 71) with the combination (29 patients) against 33 per cent (16 to 55) with chemotherapy alone (24 patients); overall response was 86 against 75 per cent. Grade 3 or worse anaemia, thrombocytopenia, lymphopenia, leucopenia and decreased appetite were at least 10 percentage points more frequent with the combination, and skin disorders, cytomegalovirus infection, fever, high blood sugar and interstitial lung disease occurred only in the combination arm. The authors describe a potentially less favourable safety profile and a higher complete response rate, providing the basis for further investigation.","status":"mixed","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov NCT01173887","url":"https://clinicaltrials.gov/study/NCT01173887"},{"label":"British Journal of Haematology 2015","url":"https://doi.org/10.1111/bjh.13338"}],"tags":["lymphoma-evidence-entities"],"related":[],"cancers":["adult-t-cell-leukaemia-lymphoma","peripheral-t-cell-lymphoma"],"sections":["immunotherapy","chemotherapy"],"technologies":["monoclonal-antibody","cytotoxic-chemotherapy"],"targets":["ccr4"],"drugs":["mogamulizumab","vincristine","cyclophosphamide","doxorubicin","prednisone","etoposide","carboplatin"],"companies":["kyowa-kirin"],"institutions":[],"pathways":[],"terms":["complete-response","lymphoma-htlv-1"],"trials":["jcog9801"],"people":[],"bottlenecks":[],"keyPapers":["paper-mlsg15-mogamulizumab-atll-bjh-2015"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01173887","phase":"2","setting":"Newly diagnosed aggressive adult T-cell leukaemia/lymphoma: dose-intensified chemotherapy (mLSG15, VCAP-AMP-VECP) with mogamulizumab against mLSG15 alone","sponsor":"Kyowa Kirin Co., Ltd.","result":"Complete response 52 against 33 per cent with the addition of mogamulizumab, with more toxicity; no survival endpoint was primary.","started":"2010-07","yearReported":2015,"enrolled":53,"enrolledBasis":"analysed","enrolledNote":"The registry records 44 enrolled; the published report gives 29 patients in the combination arm and 24 in the chemotherapy arm.","outcomes":[{"endpoint":"Complete response rate","primary":true,"unit":"%","arms":[{"name":"mLSG15 with mogamulizumab","n":29,"value":52,"note":"95 per cent confidence interval 33 to 71"},{"name":"mLSG15 alone","n":24,"value":33,"note":"95 per cent confidence interval 16 to 55"}],"source":"https://doi.org/10.1111/bjh.13338"},{"endpoint":"Overall response rate","unit":"%","arms":[{"name":"mLSG15 with mogamulizumab","n":29,"value":86},{"name":"mLSG15 alone","n":24,"value":75}],"source":"https://doi.org/10.1111/bjh.13338"}],"replication":"Not repeated in a phase 3 trial."},"route":"/trials/mlsg15-mogamulizumab-atll/","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":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"ccr4","kind":"target","name":"CCR4","route":"/targets/ccr4/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"mogamulizumab","kind":"drug","name":"Mogamulizumab","route":"/drugs/mogamulizumab/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}],"company":[{"id":"kyowa-kirin","kind":"company","name":"Kyowa Kirin","route":"/companies/kyowa-kirin/"}],"term":[{"id":"complete-response","kind":"term","name":"Complete response","route":"/terms/complete-response/"},{"id":"lymphoma-htlv-1","kind":"term","name":"HTLV-1 (human T-lymphotropic virus type 1)","route":"/terms/lymphoma-htlv-1/"}],"trial":[{"id":"jcog9801","kind":"trial","name":"JCOG9801","route":"/trials/jcog9801/"},{"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-mlsg15-mogamulizumab-atll-bjh-2015","kind":"paper","name":"Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study","route":"/key-papers/paper-mlsg15-mogamulizumab-atll-bjh-2015/"}]}}