PMID- 19896082
OWN - NLM
STAT- MEDLINE
DCOM- 20100303
LR  - 20220317
IS  - 1523-6536 (Electronic)
IS  - 1083-8791 (Linking)
VI  - 15
IP  - 12
DP  - 2009 Dec
TI  - 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.
PG  - 1578-86
LID - 10.1016/j.bbmt.2009.08.005 [doi]
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 
      >or=5 x 10(6) CD34(+) hematopoietic stem cells (HSCs)/kg compared with placebo 
      plus G-CSF (P < .001). Patients in either study arm who failed mobilization (< 
      0.8 x 10(6) CD34(+) cells/kg in 2 collections or <2 x 10(6) 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 microg/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 (>or= 2 x 
      10(6) 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.
FAU - Micallef, Ivana N
AU  - Micallef IN
AD  - Mayo Clinic, Department of Internal Medicine, Division of Hematology Rochester, 
      Minnesota, USA. Micallef.Ivana@mayo.edu
FAU - Stiff, Patrick J
AU  - Stiff PJ
FAU - DiPersio, John F
AU  - DiPersio JF
FAU - Maziarz, Richard T
AU  - Maziarz RT
FAU - McCarty, John M
AU  - McCarty JM
FAU - Bridger, Gary
AU  - Bridger G
FAU - Calandra, Gary
AU  - Calandra G
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20091004
PL  - United States
TA  - Biol Blood Marrow Transplant
JT  - Biology of blood and marrow transplantation : journal of the American Society for 
      Blood and Marrow Transplantation
JID - 9600628
RN  - 0 (Benzylamines)
RN  - 0 (Cyclams)
RN  - 0 (Heterocyclic Compounds)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
RN  - S915P5499N (plerixafor)
SB  - IM
MH  - Benzylamines
MH  - Blood Component Removal/methods
MH  - Combined Modality Therapy
MH  - Cyclams
MH  - Double-Blind Method
MH  - Female
MH  - Granulocyte Colony-Stimulating Factor/*administration & dosage/adverse effects
MH  - Hematopoietic Stem Cell Mobilization/adverse effects/*methods
MH  - Hematopoietic Stem Cell Transplantation
MH  - Heterocyclic Compounds/*administration & dosage/adverse effects
MH  - Humans
MH  - Lymphoma, Non-Hodgkin/blood/drug therapy/surgery/*therapy
MH  - Male
MH  - Middle Aged
EDAT- 2009/11/10 06:00
MHDA- 2010/03/04 06:00
CRDT- 2009/11/10 06:00
PHST- 2009/06/24 00:00 [received]
PHST- 2009/08/07 00:00 [accepted]
PHST- 2009/11/10 06:00 [entrez]
PHST- 2009/11/10 06:00 [pubmed]
PHST- 2010/03/04 06:00 [medline]
AID - S1083-8791(09)00369-3 [pii]
AID - 10.1016/j.bbmt.2009.08.005 [doi]
PST - ppublish
SO  - Biol Blood Marrow Transplant. 2009 Dec;15(12):1578-86. doi: 
      10.1016/j.bbmt.2009.08.005. Epub 2009 Oct 4.