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 Blood, 15 August 2008, Vol. 112, No. 4, pp. 990-998.
Prepublished online as a Blood First Edition Paper on April 21, 2008; DOI 10.1182/blood-2007-12-130179.

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CLINICAL TRIALS AND OBSERVATIONS

Rapid mobilization of functional donor hematopoietic cells without G-CSF using AMD3100, an antagonist of the CXCR4/SDF-1 interaction

Steven M. Devine1, Ravi Vij2, Michael Rettig2, Laura Todt2, Kiley McGlauchlen2, Nicholas Fisher2, Hollie Devine2, Daniel C. Link2, Gary Calandra3, Gary Bridger3, Peter Westervelt2, and John F. DiPersio2

1 The Ohio State University Comprehensive Cancer Center, Columbus; 2 Washington University School of Medicine, St Louis, MO; and 3 Genzyme Corporation, Cambridge, MA

Allografts from HLA-matched sibling donors were mobilized and collected without granulocyte colony-stimulating factor (G-CSF) using AMD3100, a direct antagonist of CXCR4/stromal-derived factor 1 (SDF-1/CXCL12). Donors (N = 25) were treated with AMD3100 at a dose of 240 µg/kg by subcutaneous injection, and leukapheresis was then initiated just 4 hours later. Two-thirds of the donors collected an allograft with a CD34+ cell dose sufficient for transplantation after just one dose of AMD3100. No donor experienced more than grade 1 toxicity. After a myeloablative regimen, 20 patients with hematologic malignancies received allografts collected after AMD3100 alone. All patients engrafted neutrophils (median day 10) and platelets (median day 12) promptly. Acute graft-versus-host disease (GVHD) grades 2 through 4 occurred in 35% of patients. One patient died due to complications related to acute GVHD. No unexpected adverse events were observed in any of the recipients. All 14 patients surviving in remission have robust trilineage hematopoiesis and are transfusion-free with a median follow-up of 277 days (range, 139-964 days). Direct antagonism of CXCR4 by AMD3100 may provide a more rapid and possibly less toxic and cumbersome alternative to traditional G-CSF–based mobilization in normal donors. This trial was registered as no. NCT00241358 [ClinicalTrials.gov] at www.ClinicalTrials.gov.


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