Phase I/II trial of recombinant human granulocyte-macrophage colony-stimulating factor following allogenieic bone marrow transplantation

J. Nemunaitis, C. D. Buckner, F. R. Appelbaum, C. S. Higano, M. Mori, J. Bianco, C. Epstein, J. Lipani, J. Hansen, R. Storb, E. D. Thomas, J. W. Singer

    Research output: Contribution to journalArticlepeer-review

    68 Scopus citations

    Abstract

    Forty-seven patients with hematologic neoplasia received recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) by daily 2-hour infusion following allogeneic bone marrow transplantation from HLA-identical sibling donors in a phase I-II dose-escalation trial. Dose levels ranged from 30 to 500 μg/m2/d. At doses at or below 250 μg/m2/d, toxicity felt to be caused by rhGM-CSF was negligible. However, three of five patients treated with 500 μg/m2/d had unacceptable side effects caused by rhGM-CSF. Two different graft-versus-host disease (GVHD) prophylactic regimens were administered. Twenty-seven evaluable patients were administered regimens that did not contain methotrexate (MTX) (Group I) and reached an absolute neutrophil count of 1,000/μL by a median of day 14. In contrast, 18 patients who received GVHD prophylactic regimens containing MTX (Group II) reached an absolute neutrophil count of 1,000/μL on a median of day 20. Patients in Group I had fewer febrile days and, of those discharged, had shorter initial hospitalizations than patients in Group II. The overall incidence of severe acute GVHD (grade 2 or greater) in the rhGM-CSF-treated patients was 28% and was similar to that in historical ''good risk'' patients who did not receive rhGM-CSF. These preliminary data suggest rhGM-CSF is unlikely to exacerbate GVHD in HLA-identical sibling donor transplants and indicate the need for randomized trials of rhGM-CSF in allogenic marrow transplant patients.

    Original languageEnglish (US)
    Pages (from-to)2065-2071
    Number of pages7
    JournalBlood
    Volume77
    Issue number9
    DOIs
    StatePublished - 1991

    ASJC Scopus subject areas

    • Biochemistry
    • Immunology
    • Hematology
    • Cell Biology

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