Successful Stem Cell Remobilization Using Plerixafor (Mozobil) Plus Granulocyte Colony-Stimulating Factor in Patients with Non-Hodgkin Lymphoma: Results from the Plerixafor NHL Phase 3 Study Rescue Protocol

Ivana N. Micallef, Patrick J. Stiff, John F. DiPersio, Richard T. Maziarz, John M. McCarty, Gary Bridger, Gary Calandra

Research output: Contribution to journalArticle

78 Scopus citations

Abstract

In a phase 3 multicenter, randomized, double-blinded, placebo-controlled study of 298 patients with non-Hodgkin lymphoma (NHL), granulocyte colony-stimulating factor (G-CSF) plus plerixafor increased the proportion of patients who mobilized ≥5 × 106 CD34+ hematopoietic stem cells (HSCs)/kg compared with placebo plus G-CSF (P < .001). Patients in either study arm who failed mobilization (< 0.8 × 106 CD34+ cells/kg in 2 collections or <2 × 106 CD34+ cells/kg in 4 collections) were eligible to enter the opened-label rescue protocol. Following a 7-day minimum rest period, these patients received G-CSF (10 μg/kg/day) for 4 days, followed by daily plerixafor (0.24 mg/kg) plus G-CSF and apheresis for up to 4 days. Of the 68 patients failing initial mobilization (plerixafor, n = 11; placebo, n = 57), 62 patients (91%) entered the rescue procedure (plerixafor, n = 10; placebo, n = 52). Four of 10 patients (40%) from the plerixafor group and 33 of 52 (63%) from the placebo group mobilized sufficient CD34+ cells (≥ 2 × 106 cells/kg) for transplantation from the rescue mobilization alone (P = .11). Engraftment of neutrophils (11 days) and platelets (20 days) was similar to that in patients who did not fail initial mobilization, and all patients had durable grafts at the 12-month follow-up. Common plerixafor-related adverse events (AEs) included mild gastrointestinal (GI) effects and injection site reactions. There were no drug-related serious AEs. These data support that plerixafor plus G-CSF can safely and effectively remobilize patients with NHL who have failed previous mobilization.

Original languageEnglish (US)
Pages (from-to)1578-1586
Number of pages9
JournalBiology of Blood and Marrow Transplantation
Volume15
Issue number12
DOIs
StatePublished - Dec 1 2009

Keywords

  • NHL
  • Plerixafor
  • Stem cell mobilization

ASJC Scopus subject areas

  • Hematology
  • Transplantation

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