title: Randomised comparison of two B-cell purging protocols for patients with B-cell non-Hodgkin lymphoma: in vivo purging with rituximab versus ex vivo purging with CliniMACS CD34 cell enrichment device.
abstract: We investigated the feasibility, safety and efficacy of two B-cell purging methods in patients with CD20+ non-Hodgkin lymphoma (NHL) receiving autologous stsem cell transplantation. Myeloid and immune recoveries between the methods were compared. Twenty-seven patients were randomised to either in vivo purging with rituximab or ex vivo purging by CD34+ cell selection. Both purging methods were efficient at eliminating B-cells in infusates. When compared with in vivo purging, ex vivo purging was associated with CD34+ cell loss and delayed median neutrophil (10 d vs. 11 d) and platelet (12.5 d vs. 17 d) count recoveries. Lymphocyte recovery was similar in both groups, but immunoglobulin recovery was delayed after in vivo purging. Late-infectious complications were few in both arms. At a median follow-up of 27 months, 2-year probabilities of event-free survival (EFS) rates were 81% for in vivo purging and 76% for ex vivo purging (P = 0.66). When compared with 53 unpurged patients, all 27 purged patients had improved 3-year probabilities of overall survival (89% vs. 70%, P = 0.014) and a trend for improved EFS (78% vs. 57%, P = 0.075). In conclusion, although both purging methods were feasible and safe, rituximab purging was superior as it did not impair CD34+ cell mobilisation and was associated with faster myeloid recovery. Further studies are needed to determine whether rituximab purging is more effective than the use of unpurged autografts.
authors.affiliation: Department of Medicine, Case Western Reserve University and University Hospitals of Cleveland, OH, USA.
authors.forename: Willem J
authors.initials: WJ
authors.lastname: van Heeckeren
authors.forename: Jennifer
authors.initials: J
authors.lastname: Vollweiler
authors.forename: Pingfu
authors.initials: P
authors.lastname: Fu
authors.forename: Brenda W
authors.initials: BW
authors.lastname: Cooper
authors.forename: Howard
authors.initials: H
authors.lastname: Meyerson
authors.forename: Hillard M
authors.initials: HM
authors.lastname: Lazarus
authors.forename: Alexandra
authors.initials: A
authors.lastname: Simic
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Laughlin
authors.forename: Stanton L
authors.initials: SL
authors.lastname: Gerson
authors.forename: Omer N
authors.initials: ON
authors.lastname: Koç
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D018952:Antigens, CD34 / Q000032:analysis; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016465:Bone Marrow Purging / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods; D006801:Humans; D018189:Immunomagnetic Separation / Q000379:methods; D007937:Leukapheresis / Q000379:methods; D016393:Lymphoma, B-Cell / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation / Q000379:methods*; D000069283:Rituximab
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D018952:Antigens, CD34; D000970:Antineoplastic Agents; D000069283:Rituximab