title: Allogeneic stem cell transplantation after reduced intensity conditioning in patients with relapsed or refractory Hodgkin's lymphoma. Results of the HDR-ALLO study - a prospective clinical trial by the Grupo Español de Linfomas/Trasplante de Médula Osea (GEL/TAMO) and the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation.
abstract: BACKGROUND
  Although Hodgkin's lymphoma is a highly curable disease with modern chemotherapy protocols, some patients are primary refractory or relapse after first-line chemotherapy or even after high-dose therapy and autologous stem cell transplantation. We investigated the potential role of allogeneic stem cell transplantation in this setting.
  
  
  METHODS
  In this phase II study 92 patients with relapsed Hodgkin's lymphoma and an HLA-identical sibling, a matched unrelated donor or a one antigen mismatched, unrelated donor were treated with salvage chemotherapy followed by reduced intensity allogeneic transplantation. Fourteen patients showed refractory disease and died from progressive lymphoma with a median overall survival after trial entry of 10 months (range, 6-17). Seventy-eight patients proceeded to allograft (unrelated donors, n=23). Fifty were allografted in complete or partial remission and 28 in stable disease. Fludarabine (150 mg/m(2) iv) and melphalan (140 mg/m(2) iv) were used as the conditioning regimen. Anti-thymocyte globulin was additionally used as graft-versus-host-disease prophylaxis for recipients of grafts from unrelated donors.
  
  
  RESULTS
  The non-relapse mortality rate was 8% at 100 days and 15% at 1 year. Relapse was the major cause of failure. The progression-free survival rate was 47% at 1 year and 18% at 4 years from trial entry. For the allografted population, the progression-free survival rate was 48% at 1 year and 24% at 4 years. Chronic graft-versus-host disease was associated with a lower incidence of relapse. Patients allografted in complete remission had a significantly better outcome. The overall survival rate was 71% at 1 year and 43% at 4 years.
  
  
  CONCLUSIONS
  Allogeneic stem cell transplantation can result in long-term progression-free survival in heavily pre-treated patients with Hodgkin's lymphoma. The reduced intensity conditioning approach significantly reduced non-relapse mortality; the high relapse rate represents the major remaining challenge in this setting. The HDR-Allo trial was registered in the European Clinical Trials Database (EUDRACT, https://eudract.ema.europa.eu/) with number 02-0036.
authors: Hematology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. anna.sureda@addenbrookes.nhs.uk
authors: Anna
authors: A
authors: Sureda
authors: Carme
authors: C
authors: Canals
authors: Reyes
authors: R
authors: Arranz
authors: Dolores
authors: D
authors: Caballero
authors: Josep Maria
authors: JM
authors: Ribera
authors: Mats
authors: M
authors: Brune
authors: Jacob
authors: J
authors: Passweg
authors: Rodrigo
authors: R
authors: Martino
authors: David
authors: D
authors: Valcárcel
authors: Joan
authors: J
authors: Besalduch
authors: Rafael
authors: R
authors: Duarte
authors: Angel
authors: A
authors: León
authors: Maria Jesus
authors: MJ
authors: Pascual
authors: Ana
authors: A
authors: García-Noblejas
authors: Lucia
authors: L
authors: López Corral
authors: Bianca
authors: B
authors: Xicoy
authors: Jordi
authors: J
authors: Sierra
authors: Norbert
authors: N
authors: Schmitz
mesh_terms: D000293:Adolescent; D000328:Adult; D005060:Europe; D005260:Female; D006086:Graft vs Host Disease / Q000276:immunology / Q000401:mortality; D006689:Hodgkin Disease / Q000276:immunology / Q000401:mortality / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055502:Secondary Prevention; D033581:Stem Cell Transplantation / Q000379:methods* / Q000401:mortality; D015996:Survival Rate; D019172:Transplantation Conditioning / Q000379:methods* / Q000401:mortality; D014184:Transplantation, Homologous / Q000401:mortality; D055815:Young Adult