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Chronic Lymphocytic Leukemia: Treatment

Consolidation with alemtuzumab in patients with chronic lymphocytic leukemia (CLL) in first remission – experience on safety and efficacy within a randomized multicenter phase III trial of the German CLL Study Group (GCLLSG)

Leukemia volume 18, pages 1093–1101 (2004)Cite this article

Abstract

Patients with CLL responding to initial chemotherapy with fludarabine alone (F) or in combination with cyclophosphamide (FC) were randomized for treatment with alemtuzumab (30 mg i.v. TIW, 12 weeks) or observation. Of 21 evaluable patients, 11 were randomized to alemtuzumab before the study was stopped due to severe infections in seven of 11 patients. These infections (one life-threatening pulmonary aspergillosis IV; four CMV reactivations III requiring i.v. ganciclovir; one pulmonary tuberculosis III; one herpes zoster III) were successfully treated and not associated with cumulative dose of alemtuzumab. In the observation arm, one herpes zoster infection II and one sinusitis I were documented. At 6 months after randomization, two patients in the alemtuzumab arm converted to CR, while three patients in the observation arm progressed. After alemtuzumab treatment, five of six patients achieved a molecular remission in peripheral blood while all patients in the observation arm remained MRD-positive (P=0.048). At 21.4 months median follow-up, patients receiving alemtuzumab showed a significant longer progression-free survival (no progression vs mean 24.7 months; P=0.036). In conclusion, a consolidation therapy with alemtuzumab is able to achieve molecular remissions and longer survival in CLL, but a safe treatment regimen needs to be determined.

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Acknowledgements

We are grateful to the following colleagues taking care of patients being enrolled on study protocol: Dr Abenhardt, Munich; PD Dr Benz, Tübingen; Professor Dr Dührsen, Essen; Dr Fiedler, Chemnitz; Dr Freier, Hildesheim; Dr Hopfinger, Wien; Dr Kamp, Wendlingen; Dr Lambertz, Garmisch-Partenkirchen; Dr Lindemann, Hagen; Dr Middecke, Lemgo; PD Dr Mittermüller, Munich; Dr Pasold, Potsdam; Dr Srock, Berlin; Dr Stauch, Kronach; Dr Ziegler, Erlangen. We appreciate especially the support of D. Egger and Dr Grassmann, Medac-Schering Onkologie GmbH, and Dr Kuhlmann, Schering AG. We thank Dr Hillmen and Dr Hale for inspiring discussions. This study was supported by a grant from Schering AG and ILEX Oncology.

Author information

Authors and Affiliations

  1. Klinikum Grosshadern, Medical Clinic III, Ludwig-Maximilians-University, Munich, Germany

    C-M Wendtner, C D Schweighofer, G Fingerle-Rowson, B Eichhorst & M Hallek

  2. Medical Clinic II, University Hospital, Kiel, Germany

    M Ritgen & M Kneba

  3. Max-von-Pettenkofer-Institute, Ludwig-Maximilians-University, Munich, Germany

    H Campe & G Jäger

  4. Institute of Medical Statistics and Epidemiology, Technical University, Munich, Germany

    R Busch

  5. Clinical Chemistry, Ludwig-Maximilians-University, Munich, Germany

    H Diem

  6. Medical Clinic I, University Hospital, Cologne, Germany

    C-M Wendtner, C D Schweighofer, G Fingerle-Rowson, A Engert & M Hallek

  7. Medical Clinic III, University Hospital Ulm, Germany

    S Stilgenbauer & H Döhner

  8. Medizinische Klinik Innenstadt, Ludwig-Maximilians-University, Munich, Germany

    B Emmerich

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the German CLL Study Group (GCLLSG)

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Presented, in part, at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31–June 3, 2003, and the 45th Annual Meeting of the American Society of Hematology, San Diego, CA, December 6–9, 2003.

Supported by a research grant of Schering AG, Berlin and MedacSchering Onkologie, Germany. VH sequencing was supported by a research grant from the Else Kröner-Fresenius Stiftung, Germany.

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Wendtner, CM., Ritgen, M., Schweighofer, C. et al. Consolidation with alemtuzumab in patients with chronic lymphocytic leukemia (CLL) in first remission – experience on safety and efficacy within a randomized multicenter phase III trial of the German CLL Study Group (GCLLSG). Leukemia 18, 1093–1101 (2004). https://doi.org/10.1038/sj.leu.2403354

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