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Lymphoma

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

Leukemia volume 35, pages 143–155 (2021)Cite this article

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Abstract

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.

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Fig. 1: CONSORT diagram of the DSHNHL2006-1B/ACT-2 trial.
Fig. 2: Protocol adherence.
Fig. 3: Survival according to treatment arms.
Fig. 4: Survival according to IPI.

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Acknowledgements

The authors would like to thank the patients who participated in this study and their families, as well as the staff at all clinical sites. We gratefully appreciate the commitment of data management staff (Beate Mann, Katja Rillich, Martina Kunert, Barbara Wicklein) at the IMISE, University of Leipzig. We are particularly grateful for the dedicated work of Elke Stitz at the T-NHL office at the UMG.

Funding

Bundesministerium für Bildung und Forschung (BMBF, FKZ 01KG0705); Genzyme-Sanofi (unrestricted grant).

Author information

Author notes

  1. These authors contributed equally: Gerald G. Wulf, Bettina Altmann

  2. Deceased: Michael Pfreundschuh

Authors and Affiliations

  1. Hematology and Medical Oncology, University Medicine Goettingen, Goettingen, Germany

    Gerald G. Wulf, Friederike Braulke & Lorenz Trümper

  2. Institute for Medical Informatics, Statistics and Epidemiology, University Leipzig, Leipzig, Germany

    Bettina Altmann, Marita Ziepert & Markus Loeffler

  3. Department of Hematology, Aarhus University Hospital, Aarhus, Denmark

    Francesco D’Amore

  4. Internal Medicine 1, Westpfalz-Klinikum, Kaiserslautern, Germany

    Gerhard Held

  5. Department of internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Cancer Research Institute, Salzburg, Austria

    Richard Greil

  6. Laboratory for Immunological and Molecular Cancer Research (SCI-LIMCR), Paracelsus Medical University, Cancer Cluster Salzburg, Salzburg, Austria

    Richard Greil

  7. Service de therapie cellullaire et Hematologie Clinique adulte, CHU Estaing, Clermont-Ferrand, France

    Olivier Tournilhac

  8. Department of Clinical Sciences Lund, Lund University Hospital, Lund, Sweden

    Thomas Relander

  9. Department Internal Medicine III, University Hospital of Ulm, Ulm, Germany

    Andreas Viardot

  10. Paracelsus Medical University, Medizinische Klinik 5, Klinikum Nuernberg, Nuernberg, Germany

    Martin Wilhelm

  11. Department of Hematology, University Hospital Marburg, Marburg, Germany

    Christian Wilhelm

  12. Medizinische Klinik mit Schwerpunkt Hämatologie/Onkologie Campus Virchow-Klinikum, Charite, Berlin, Germany

    Antonio Pezzutto

  13. Department of Hematology, Vrije Universiteit Medisch Centrum Amsterdam, Amsterdam, The Netherlands

    Josee M. Zijlstra

  14. Cliniques universitaires UCL Saint-Luc, Brussels, Belgium

    Eric Van Den Neste

  15. Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands

    Pieternella J. Lugtenburg & Jeanette K. Doorduijn

  16. Department of Hematology, Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands

    Michel van Gelder

  17. Department of Hematology, University Medical Centre Groningen, Groningen, The Netherlands

    Gustaaf W. van Imhoff

  18. Klinikum Traunstein, Department Hematology and Oncology, Traunstein, Germany

    Florian Zettl

  19. Onkologie Lerchenfeld, Hamburg, Germany

    Maike Nickelsen

  20. HELIOS Klinikum Berlin-Buch, Berlin, Germany

    Bertram Glass

  21. Institute of Pathology, University of Wuerzburg and Comprehensive Cancer Centre (CCC) Mainfranken, Wuerzburg, Germany

    Andreas Rosenwald

  22. Department of Pathology, Hospital Henri Mondor, APHP, Inserm U955, Université Paris-Est, Créteil, France

    Philippe Gaulard

  23. Department of Hematology and Oncology, University Hospital Saarland, Homburg, Germany

    Michael Pfreundschuh

  24. Department of Hematology, Oncology, Haemostaseology, and Pneumology, University Hospital, Muenster, Germany

    Norbert Schmitz

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Contributions

Study conception and design: LT, GGW, NS, MZ, ML. Collection and assembly of data: All authors. Data analysis and interpretation: BA, MZ, ML, GGW, NS, LT. Provision of study materials or patients: All authors. Drafting or revising the manuscript: GGW, BA, MZ, NS, LT. Review and approval of the final version of the manuscript: All authors.

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Correspondence to Gerald G. Wulf.

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Wulf, G.G., Altmann, B., Ziepert, M. et al. Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial. Leukemia 35, 143–155 (2021). https://doi.org/10.1038/s41375-020-0838-5

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