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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.
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.
Complete 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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
53 analysed.
95 per cent confidence interval 33 to 71 · 95 per cent confidence interval 16 to 55
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete response rateprimary | mLSG15 with mogamulizumab | 29 | 52% | - | - | link |
| mLSG15 alone | 24 | 33% | ||||
| Overall response rate | mLSG15 with mogamulizumab | 29 | 86% | - | - | link |
| mLSG15 alone | 24 | 75% |
Shares HTLV-1 (human T-lymphotropic virus type 1), Mogamulizumab phase 2 in relapsed adult T-cell leukaemia/lymphoma (Japan), Kyowa Kirin, CCR4 and the tag lymphoma-evidence-entities.
Shares Mogamulizumab phase 2 in relapsed adult T-cell leukaemia/lymphoma (Japan), CCR4, Mogamulizumab, Adult T-cell leukaemia/lymphoma and the tag lymphoma-evidence-entities.
Shares HTLV-1 (human T-lymphotropic virus type 1), Mogamulizumab phase 2 in relapsed adult T-cell leukaemia/lymphoma (Japan), Adult T-cell leukaemia/lymphoma, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma) and the tag lymphoma-evidence-entities.
Shares CCR4, Mogamulizumab, Adult T-cell leukaemia/lymphoma and the tag lymphoma-evidence-entities.
Shares Prednisone, Vincristine, Etoposide, Doxorubicin and the tag lymphoma-evidence-entities.
Shares Prednisone, Vincristine, Etoposide, Doxorubicin and the tag lymphoma-evidence-entities.
Shares Etoposide, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma), Carboplatin, Cytotoxic chemotherapy and the tag lymphoma-evidence-entities.
Shares Complete response, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma) and the tag lymphoma-evidence-entities.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/