Alemtuzumab as Treatment of Steroid-Refractory Acute Graft-versus-Host Disease: Results of a Phase II Study

We conducted a phase II trial to investigate the safety and efficacy of alemtuzumab in treating steroid-refractory acute graft-versus-host disease (aGVHD) grade II or higher after stem cell transplantation. Ten adult patients (6 with aGVHD grade III and 4 with aGVHD grade IV) were included in the st...

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Bibliographic Details
Authors: Martinez, Carmen, Solano, Carlos, Ferra, Christelle, Sampol Mayol, Antonia, Valcarcel, David, Perez-Simon, Jose Antonio, Spanish Grp Stem Cell Transplantat
Format: article
Publication Date:2009
Country:España
Institution:Conselleria de Salut i Consum del Govern de les Illes Balears
Repository:Docusalut
Language:English
OAI Identifier:oai:docusalut.com:20.500.13003/17379
Online Access:https://hdl.handle.net/20.500.13003/17379
Access Level:Open access
Keyword:Gastrointestinal Diseases
Steroids
Skin Diseases
Survival Rate
Treatment Outcome
Female
Salvage Therapy
Male
Graft vs Host Disease
Opportunistic Infections
Alemtuzumab
Middle Aged
Antineoplastic Agents
Cause of Death
Aged
Young Adult
Acute Disease
Antibodies, Neoplasm
Hematopoietic Stem Cell Transplantation
Adult
Antibodies, Monoclonal
Humans
Antibodies, Monoclonal, Humanized
Liver Diseases
Enfermedad Aguda
Anticuerpos Monoclonales
Anciano
Masculino
Antineoplásicos
Enfermedades Gastrointestinales
Anticuerpos Monoclonales Humanizados
Trasplante de Células Madre Hematopoyéticas
Humanos
Terapia Recuperativa
Persona de Mediana Edad
Adulto Joven
Causas de Muerte
Hepatopatías
Femenino
Infecciones Oportunistas
Enfermedad Injerto contra Huésped
Tasa de Supervivencia
Esteroides
Resultado del Tratamiento
Anticuerpos Antineoplásicos
Enfermedades de la Piel
Adulto
Acute graft-versus-host disease
Allogeneic stem cell transplantation
Description
Summary:We conducted a phase II trial to investigate the safety and efficacy of alemtuzumab in treating steroid-refractory acute graft-versus-host disease (aGVHD) grade II or higher after stem cell transplantation. Ten adult patients (6 with aGVHD grade III and 4 with aGVHD grade IV) were included in the study. Nine patients had gastrointestinal tract involvement, 7 had skin involvement, and 5 had liver involvement. Five patients responded to treatment, 2 with complete response and 3 with partial response. Eight infectious events (4 of grade 3-4) and 7 cytomegalovirus (CMV) reactivations were observed. Six patients had grade 3-4 cytopenia. All 10 patients died (7 resulting from aGVHD progression, 2 from severe infection, and I from to leukemia relapse), at a median of 40 days (range, 4 to 88 days) after alemtuzumab treatment. Overall, our findings suggest that steroid-refractory aGVHD may be improved by treatment with alemtuzumab, but that this treatment does not overcome the dismal prognosis of patients with severe aGVHD, demonstrating the need for alternative therapies to treat this complication.