title: A prospective clinical trial evaluating the safety and efficacy of the combination of rituximab and plerixafor as a mobilization regimen for patients with lymphoma.
abstract: BACKGROUND
  Previous reports suggested that rituximab may impair stem cell collection and posttransplant engraftment in lymphoma patients undergoing autologous hematopoietic progenitor cell transplantation.
  
  
  METHODS
  A prospective biologic allocation study examined the effect of adding rituximab to a mobilization regimen of plerixafor and granulocyte-colony-stimulating factor (G-CSF) for patients with CD20+ lymphoma compared with CD20- lymphoma patients mobilized without rituximab. The primary endpoint was safety of the rituximab-containing regimen; secondary endpoints compared the efficiency of stem cell collection, posttransplant engraftment, graft characteristics, mobilization kinetics, immune reconstitution, and engraftment durability between the cohorts of patients with CD20+ and CD20- lymphoma.
  
  
  RESULTS
  Fifteen subjects assigned to each treatment arm were accrued. Both mobilization regimens had similar toxicities. The median number of CD34+ cells collected (7.4 × 10(6) /kg vs. 6.4 × 10(6) /kg) and the median numbers of days of apheresis needed to collect stem cells were not different between the CD20+ and CD20- cohorts. No significant differences in neutrophil engraftment (median, 13.5 days vs. 13 days) or platelet engraftment (22 vs. 21 days) or in graft durability were seen comparing patients with CD20+ versus CD20- lymphoma. There were no significant differences in the kinetics of blood T-cell or natural killer-cell reconstitution comparing the two groups. B-cell reconstitution was delayed in the CD20+ lymphoma group, but this did not translate into a significant increase in infectious complications.
  
  
  CONCLUSIONS
  Rituximab can be safely added to the combination of plerixafor and G-CSF as a mobilization strategy without excess toxicity or posttransplant engraftment delays for patients with chemosensitive lymphoma undergoing autologous hematopoietic progenitor cell transplantation.
authors.affiliation: Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA 30322, USA.
authors.forename: Jonathan L
authors.initials: JL
authors.lastname: Kaufman
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Flowers
authors.forename: Karen D
authors.initials: KD
authors.lastname: Rados
authors.forename: Gary B
authors.initials: GB
authors.lastname: Calandra
authors.forename: Julie M
authors.initials: JM
authors.lastname: Vose
authors.forename: L Becker
authors.initials: LB
authors.lastname: Hewes
authors.forename: Sagar
authors.initials: S
authors.lastname: Lonial
authors.forename: Amelia A
authors.initials: AA
authors.lastname: Langston
authors.forename: H Jean
authors.initials: HJ
authors.lastname: Khoury
authors.forename: Mary Jo
authors.initials: MJ
authors.lastname: Lechowicz
authors.forename: Edmund K
authors.initials: EK
authors.lastname: Waller
mesh_terms: D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001596:Benzylamines; D000080027:Cyclams; D016179:Granulocyte Colony-Stimulating Factor / Q000378:metabolism; D006571:Heterocyclic Compounds / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy* / Q000378:metabolism / Q000628:therapy; D000069283:Rituximab; D033581:Stem Cell Transplantation
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D001596:Benzylamines; D000080027:Cyclams; D006571:Heterocyclic Compounds; D016179:Granulocyte Colony-Stimulating Factor; D000069283:Rituximab; C088327:plerixafor