title: Reduced-intensity allogeneic transplantation provides high event-free and overall survival in patients with advanced indolent B cell malignancies: CALGB 109901.
abstract: Cancer and Leukemia Group B conducted a phase II study to evaluate the safety and efficacy of a reduced-intensity conditioning regimen with allogeneic transplantation to treat patients with recurrent low-grade B cell malignancies. Patients over age 18 with a diagnosis of relapsed, chemotherapy-sensitive disease underwent transplantation with a matched sibling donor, and conditioning with cyclophosphamide (1 g/m(2)/day × 3) and fludarabine phosphate (25 mg/m(2)/day × 5). Graft-versus-host prophylaxis included cyclosporine or tacrolimus plus low-dose methotrexate. Forty-four evaluable patients with a median age of 53 and median of 2 prior regimens were accrued. Sixteen patients had follicular non-Hodgkin lymphoma and 28 had histologies including 7 indolent B cell lymphomas, 4 mantle cell, 15 chronic lymphocytic leukemia (CLL), and 2 prolymphocytic leukemia (PLL) patients. The 6-month treatment-related mortality (TRM) was 2.4% and 3-year TRM was 9%. Three-year event-free and overall survival were 0.75 and 0.81 for the follicular patients, 0.59 and 0.71 for the CLL/PLL patients, and 0.55 and 0.64 for the other histologies. The incidence of grade II-IV acute graft-versus-host disease (GVHD) was 29%, and extensive chronic GVHD was 18%. This report demonstrates that allogeneic sibling transplantation with a reduced-intensity conditioning regimen is safe and efficacious for patients with advanced indolent B cell malignancies enrolled on a Cooperative Group study.
authors.affiliation: University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599, USA. sheat@med.unc.edu
authors.forename: Thomas
authors.initials: T
authors.lastname: Shea
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Johnson
authors.forename: Peter
authors.initials: P
authors.lastname: Westervelt
authors.forename: Sherif
authors.initials: S
authors.lastname: Farag
authors.forename: John
authors.initials: J
authors.lastname: McCarty
authors.forename: Asad
authors.initials: A
authors.lastname: Bashey
authors.forename: Luis
authors.initials: L
authors.lastname: Isola
authors.forename: Lee-Anne
authors.initials: LA
authors.lastname: Baxter-Lowe
authors.forename: Michael
authors.initials: M
authors.lastname: Kelly
authors.forename: Kouros
authors.initials: K
authors.lastname: Owzar
authors.forename: Charles
authors.initials: C
authors.lastname: Linker
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods* / Q000401:mortality; D006801:Humans; D015448:Leukemia, B-Cell / Q000401:mortality / Q000628:therapy*; D016393:Lymphoma, B-Cell / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D019172:Transplantation Conditioning / Q000379:methods*; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D001084:Vidarabine Phosphate / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D001084:Vidarabine Phosphate; C042382:fludarabine phosphate; D003520:Cyclophosphamide