Originally published as JCO Early Release 10.1200/JCO.2008.20.7209 on August 31 2009

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Phase III Prospective Randomized Double-Blind Placebo-Controlled Trial of Plerixafor Plus Granulocyte Colony-Stimulating Factor Compared With Placebo Plus Granulocyte Colony-Stimulating Factor for Autologous Stem-Cell Mobilization and Transplantation for Patients With Non-Hodgkin's Lymphoma

From Washington University, St Louis, MO; Mayo Clinic, Rochester, MN; Loyola University, Maywood, IL; Cleveland Clinic, Cleveland, OH; Oregon Health & Science University, Portland, OR; Dana-Farber Cancer Institute, Boston; Genzyme Corporation, Cambridge, MA (formerly AnorMED Inc); City of Hope National Medical Center; Duarte, CA; and Virginia Commonwealth University, Richmond, VA.

Corresponding author: John F. DiPersio, MD, PhD, Division of Oncology, Siteman Cancer Center, Washington University School of Medicine, St Louis, MO; e-mail: jdipersi{at}im.wustl.edu.

Purpose This study evaluates the safety and efficacy of plerixafor (AMD3100), a CXCR4 antagonist, in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin's lymphoma (NHL) patients.

Patients and Methods This is a phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study. Patients with non-Hodgkin's lymphoma requiring an autologous hematopoietic stem-cell transplantation in first or second complete or partial remission were eligible. Patients received granulocyte colony-stimulating factor (G-CSF; 10 µg/kg) subcutaneously daily for up to 8 days. Beginning on evening of day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 µg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until 5 x 10⁶ CD34+ cells/kg were collected. The primary end point was the percentage of patients who collected 5 x 10⁶ CD34+ cells/kg in 4 or fewer apheresis days.

Results This report presents all data for all patients (n = 298) through 12 months follow-up. Eighty-nine (59%) of 150 patients in the plerixafor group and 29 (20%) of 148 patients in the placebo group met the primary end point (P < .001). One hundred thirty-five patients (90%) in plerixafor group and 82 patients (55%) in placebo group underwent transplantation after initial mobilization. Median time to engraftment was similar in both groups. The most common plerixafor-associated adverse events were GI disorders and injection site reactions.

Conclusion Plerixafor and G-CSF were well tolerated and resulted in a significantly higher proportion of patients with non-Hodgkin's lymphoma achieving the optimal CD34+ cell target for transplantation in fewer apheresis days, compared with G-CSF alone.

Supported and sponsored by Genzyme Corporation, Cambridge, MA (formerly AnorMED Inc).

Presented in part at the 49th Annual Meeting of the American Society of Hematology, December 8-11, 2007.

Written on behalf of the 3101 Investigators.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on JCO.org.

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