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 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 1 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.
Martínez
Carmen
C
Hematology Department, Hematopoietic Transplantation Unit, Institute of Hematology and Oncology, Hospital Clinic, Barcelona, Spain. cmarti@clinic.ub.es
Solano
Carlos
C
Ferrá
Christelle
C
Sampol
Antonia
A
Valcárcel
David
D
Pérez-Simón
José Antonio
JA
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000633:toxicity; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000008:administration & dosage* / Q000633:toxicity; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000633:toxicity; D002423:Cause of Death; D005260:Female; D005767:Gastrointestinal Diseases; D006086:Graft vs Host Disease / Q000188:drug therapy*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006801:Humans; D008107:Liver Diseases; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections; D016879:Salvage Therapy; D012871:Skin Diseases; D013256:Steroids / Q000627:therapeutic use; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D000970:Antineoplastic Agents; D013256:Steroids; D000074323:Alemtuzumab