TY - JOUR
T1 - Successful Stem Cell Remobilization Using Plerixafor (Mozobil) Plus Granulocyte Colony-Stimulating Factor in Patients with Non-Hodgkin Lymphoma
T2 - Results from the Plerixafor NHL Phase 3 Study Rescue Protocol
AU - Micallef, Ivana N.
AU - Stiff, Patrick J.
AU - DiPersio, John F.
AU - Maziarz, Richard T.
AU - McCarty, John M.
AU - Bridger, Gary
AU - Calandra, Gary
N1 - Funding Information:
Financial disclosure: This study was wholly supported by research funding from Genzyme Corporation. The authors thank Sachin Marulkar, Genzyme Corporation, for statistical support and Andrew Dye and Pritesh Gandhi, Genzyme Corporation, for help with the content and coordination of manuscript revisions. P.J.S. and R.T.M. received research funding and honoraria from Genzyme Corporation. I.N.M. received research funding from Genzyme Corporation. J.F.D. received honoraria from Genzyme Corporation. J.M. received honoraria and research funding from Genzyme Corporation and Celgene Corporation. G.B. and G.C. were formerly employees of AnorMed Incorporated and now serve as consultants for Genzyme Corporation.
PY - 2009/12
Y1 - 2009/12
N2 - 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.
AB - 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.
KW - NHL
KW - Plerixafor
KW - Stem cell mobilization
UR - http://www.scopus.com/inward/record.url?scp=70350566151&partnerID=8YFLogxK
U2 - 10.1016/j.bbmt.2009.08.005
DO - 10.1016/j.bbmt.2009.08.005
M3 - Article
C2 - 19896082
AN - SCOPUS:70350566151
SN - 1083-8791
VL - 15
SP - 1578
EP - 1586
JO - Biology of Blood and Marrow Transplantation
JF - Biology of Blood and Marrow Transplantation
IS - 12
ER -