Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial

ACT-2 Study Investigators, Gerald G. Wulf*, Bettina Altmann, Marita Ziepert, Francesco D'Amore, Gerhard Held, Richard Greil, Olivier Tournilhac, Thomas Relander, Andreas Viardot, Martin Wilhelm, Christian Wilhelm, Antonio Pezzutto, Josee M. Zijlstra, Eric Van Den Neste, Pieternella J. Lugtenburg, Jeanette K. Doorduijn, Michel van Gelder, Gustaaf W. van Imhoff, Florian ZettlFriederike Braulke, Maike Nickelsen, Bertram Glass, Andreas Rosenwald, Philippe Gaulard, Markus Loeffler, Michael Pfreundschuh, Norbert Schmitz, Lorenz Truemper

*Corresponding author for this work

    Research output: Contribution to journalArticleAcademicpeer-review

    57 Citations (Scopus)
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    PTCL patients exhibit poor survival with existing treatments. We investigated the efficacy of CHOP combined with alemtuzumab in 116 PTCL patients age 61-80 in an open-label, randomized phase 3 trial. Alemtuzumab was given on day 1, to a total of 360 mg in 21 patients, or 120 mg in 37. Hematotoxicity was increased with A-CHOP resulting in more grade >= 3 infections (40% versus 21%) and 4 versus 1 death due to infections, respectively. CR/CRu rate was 60% for A-CHOP and 43% for CHOP, and OR rate was 72% and 66%, respectively. Three-year-EFS, PFS and OS were 27% [15%-39%], 28% [15%-40%], and 37% ([23%-50%] for A-CHOP, and 24% [12%-35%], 29% [17%-41%], and 56% [44%-69%] for CHOP, respectively, showing no significant differences. Multivariate analyses, adjusted for strata and sex confirmed these results (hazard ratio HREFS: 0.7 ([95% CI: 0.5-1.1]; p = 0.094), HRPFS: 0.8 ([95% CI: 0.5-1.2]; p = 0.271), HROS: 1.4 ([95% CI: 0.9-2.4]; p = 0.154). The IPI score was validated, and male sex (HREFS 2.5) and bulky disease (HREFS 2.2) were significant risk factors for EFS, PFS, and OS. Alemtuzumab added to CHOP increased response rates, but did not improve survival due to treatment-related toxicity.

    Original languageEnglish
    Pages (from-to)143-155
    Number of pages13
    Issue number1
    Publication statusPublished - Jan-2021


    • PHASE-II


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