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Conditioning Regimens

Priming with r-metHuSCF and filgrastim or chemotherapy and filgrastim in patients with malignant lymphomas: a randomized phase II pilot study of mobilization and engraftment

Bone Marrow Transplantation volume 46, pages 44–51 (2011)Cite this article

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Abstract

SCF has been shown to synergize with G-CSF to mobilize CD34+ PBPCs. In this study we report results from this combination after a phase II trial of 32 patients with malignant lymphoma randomized to receive recombinant methionyl human SCF (ancestim, r-metHuSCF) in combination with recombinant methionyl human G-CSF (filgrastim, r-metHuG-CSF) (experimental arm A) or routine chemotherapy plus filgrastim (conventional arm B). The primary objective was to evaluate the side effects and toxicity during priming and mobilization. The secondary objectives were efficacy by the level of blood-circulating PBPCs, the number of harvest days and the time to three-lineage engraftment after autografting. First, during priming 5 patients had 8 serious events, 4 in each arm. A summary of all adverse events revealed 30 (94%) patients suffering from 132 events of all grading. Second, neutropenia and thrombocytopenia was documented in arm B. Third, 9/14 (64%) patients in arm A reached the target of 5 million CD34+ cells/kg body weight (bw) compared with 13/15 (87%) in arm B. The results represent the first randomized trial of growth factor plus chemotherapy priming and indicate that a formal phase III trial very unlikely may challenge chemotherapy plus r-metHuG-CSF priming in candidates for high-dose therapy.

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Acknowledgements

This study was investigator driven and supported by unrestricted grants, human resources and drug delivery from Amgen and by research grants to HEJ from the Nordic Cancer Union (Grant no. 56-9350/56-9351 and 56 100 02-9101/9102 95) and Danish Cancer Society (Grant no. 945 100-15) to the Nordic Stem Cell Laboratory Group (NSCL-G) and The Nordic Lymphoma Group (NLG).

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Authors and Affiliations

  1. Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark

    H E Johnsen, A Schmitz & M Boegsted

  2. Herlev University Hospital, Copenhagen, Denmark

    H E Johnsen, G W Jürgensen, L M Pedersen & O J Bergmann

  3. Rigshospitalet, Copenhagen, Denmark

    C Geisler

  4. University Hospital, Helsinki, Finland

    E Juvonen

  5. University Hospital, Turku, Finland

    K Remes

  6. University Hospital, Link, ö, ping, Sweden

    G Juliusson

  7. University Hospital, Ume, å, Sweden

    P Hörnsten

  8. Radiumhospitalet, Oslo, Norway

    S Kvaloy & G Kvalheim

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  1. H E Johnsen
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Correspondence to H E Johnsen.

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Johnsen, H., Geisler, C., Juvonen, E. et al. Priming with r-metHuSCF and filgrastim or chemotherapy and filgrastim in patients with malignant lymphomas: a randomized phase II pilot study of mobilization and engraftment. Bone Marrow Transplant 46, 44–51 (2011). https://doi.org/10.1038/bmt.2010.84

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