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
Cabrero, Monica (Hospital Universitario de Salamanca)
Martín García-Sancho, Alejandro (Hospital Universitario de Salamanca)
Briones Meijide, Javier (Institut d'Investigació Biomèdica Sant Pau)
Gayoso, Jorge (Hospital General Universitario Gregorio Marañón)
Jarque, Isidro (Hospital Universitari i Politècnic La Fe (València))
López, Javier (Hospital Universitario Ramón y Cajal (Madrid))
Grande García, Carlos (Hospital 12 de Octubre (Madrid))
Heras, Inmaculada (Hospital General Universitario Morales Meseguer (Múrcia))
Arranz, Reyes (Hospital Universitario de la Princesa (Madrid))
Bernal, Teresa (Hospital Universitario Central de Asturias)
Perez-Lopez, Estefenia (Hospital Universitario de Salamanca)
López-Godino, Oriana (Hospital General Universitario Morales Meseguer (Múrcia))
Conde, Eulogio (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Caballero, Dolores (Hospital Universitario de Salamanca)
Universitat Autònoma de Barcelona

Date:	2017
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/m i. v. (days -3 and -2) plus melphalan 70 mg/m i. 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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Allogeneic transplantation ; B cell lymphoma ; Clinical trial ; Radioimmunotherapy ; Reduced-intensity conditioning
Published in:	Biology of blood and marrow transplantation, Vol. 23 Núm. 1 (january 2017) , p. 53-59, ISSN 1523-6536

DOI: 10.1016/j.bbmt.2016.10.003
PMID: 27771496

7 p, 784.4 KB

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