title: Phase II Study of Yttrium-90-Ibritumomab Tiuxetan as Part of Reduced-Intensity Conditioning (with Melphalan, Fludarabine ± Thiotepa) for Allogeneic Transplantation in Relapsed or Refractory Aggressive B Cell Lymphoma: A GELTAMO Trial.
abstract: We designed a phase II clinical trial including Y-90 ibritumomab-tiuxetan as part of a reduced-intensity conditioning (RIC) allogeneic stem cell transplantation (AlloSCT) in high-risk non-Hodgkin lymphoma (Clinical Trials Identifier: NCT00644371). Eligible patients had high-risk relapsed/refractory aggressive lymphoma. The conditioning regimen consisted of rituximab 250 mg (days -21 and -14), Y-90 ibritumomab IV (.4 m Ci/kg, day -14), fludarabine 30 mg/m2i.v. (days -3 and -2) plus melphalan 70 mg/m2i.v. (days -3 and -2) or 1 dose of melphalan and thiotepa 5 mg/kg (day -8). Donors were related. Eighteen patients were evaluable. At the time of transplantation, responses were complete remission (CR) (n = 7, 39%), partial remission (n = 6, 33%) or refractory disease (n = 4, 28%). Y-90-ibritumomab infusions were well tolerated, with no adverse reactions. Nonrelapse mortality at 1 year was 28%. Median follow-up was 46 (range, 39 to 55) months. Estimated 1-year progression-free survival (PFS) was 50%, and 4-year overall survival (OS) and PFS were both 44.4%. CR at the moment of AlloSCT had significant impact on PFS (71% versus 27%, P = .046) and OS (71% versus 27%, P = .047). Our results show that Y-90-ibritumomab-tiuxetan as a component of RIC for AlloSCT is feasible in patients with high-risk B cell lymphoma. Development of phase III clinical trials is needed to clarify the contribution of radioimmunotherapy to RIC AlloSCT.
authors: Hematology Department, Hospital Universitario Salamanca and IBSAL (Instituto Biosanitario de Salamanca), Spain.
authors: Monica
authors: M
authors: Cabrero
authors: Hematology Department, Hospital Universitario Salamanca and IBSAL (Instituto Biosanitario de Salamanca), Spain. Electronic address: amartingar@usal.es.
authors: Alejandro
authors: A
authors: Martin
authors: Department of Hematology, Hospital Santa Creu i Sant Pau, Barcelona, Spain.
authors: Javier
authors: J
authors: Briones
authors: Department of Hematology, Hospital Gregorio Marañon, Madrid, Spain.
authors: Jorge
authors: J
authors: Gayoso
authors: Department of Hematology, Hospital La Fe, Valencia, Spain.
authors: Isidro
authors: I
authors: Jarque
authors: Department of Hematology, Hospital Ramón y Cajal, Madrid, Spain.
authors: Javier
authors: J
authors: López
authors: Department of Hematology, Hospital 12 de Octubre, Madrid, Spain.
authors: Carlos
authors: C
authors: Grande
authors: Department of Hematology, Hospital Morales Messeguer, Murcia, Spain.
authors: Inmaculada
authors: I
authors: Heras
authors: Department of Hematology, Hospital La Princesa, Madrid, Spain.
authors: Reyes
authors: R
authors: Arranz
authors: Department of Hematology, Hospital Central de Asturias, Oviedo, Spain.
authors: Teresa
authors: T
authors: Bernal
authors: Hematology Department, Hospital Universitario Salamanca and IBSAL (Instituto Biosanitario de Salamanca), Spain.
authors: Estefania
authors: E
authors: Perez-Lopez
authors: Department of Hematology, Hospital Morales Messeguer, Murcia, Spain.
authors: Oriana
authors: O
authors: López-Godino
authors: Department of Hematology, Hospital Marqués de Valdecilla, Santander, Spain.
authors: Eulogio
authors: E
authors: Conde
authors: Hematology Department, Hospital Universitario Salamanca and IBSAL (Instituto Biosanitario de Salamanca), Spain.
authors: Dolores
authors: D
authors: Caballero
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods / Q000401:mortality; D006801:Humans; D016393:Lymphoma, B-Cell / Q000401:mortality / Q000628:therapy*; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D016499:Radioimmunotherapy / Q000379:methods / Q000401:mortality; D016879:Salvage Therapy / Q000379:methods* / Q000401:mortality; D016019:Survival Analysis; D013852:Thiotepa / Q000008:administration & dosage; D019172:Transplantation Conditioning / Q000379:methods* / Q000401:mortality; D014184:Transplantation, Homologous; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives; D015021:Yttrium Radioisotopes / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D015021:Yttrium Radioisotopes; C422802:ibritumomab tiuxetan; D013852:Thiotepa; D014740:Vidarabine; C024352:fludarabine; D008558:Melphalan
keywords: Allogeneic transplantation; B cell lymphoma; Clinical trial; Radioimmunotherapy; Reduced-intensity conditioning