Yazarlar : van Besien K, Stock W, Rich E, Odenike O, Godley LA, O'Donnell PH, Kline J, Nguyen V, Cerro PD, Larson RA, Artz AS.

Yayın : Biol Blood Marrow Transplant.

Yayın Yılı : 2011

Pubmed Linki : http://www.ncbi.nlm.nih.gov/pubmed/22079470

Konu : Kemik İliği Nakli

Literatür İçeriği :  

Abstract

We conducted a phase I-II study of transplant conditioning with clofarabine-melphalan -alemtuzumab for patients with advanced hematologic malignancies. Ten patients were accrued to the phase I portion which utilized an accelerated titration design. No DLT was observed and clofarabine 40 mg/m2 x5, melphalan 140 mg/m2x1 and alemtuzumab 20 mgx5 was adopted for the phase II study which accrued 72 patients. Median age was 54 years. There were 44 AML or MDS, 27 NHL, 9 other hematologic malignancies. The largest subgroup of 35 patients had ASBMT high risk, active disease. All evaluable patients engrafted with a median time to neutrophil and platelet recovery of 10 and 18 days respectively. The cumulative incidence of treatment related mortality was 26% at 1 year. Cumulative incidence of relapse was 29% at 1 year. OS was 80% (95% CI 71-89) at 100 days and 59% (95% CI 47-71) at 1 year. PFS was 45% (95% CI 33-67) at 1 year. Rapid onset renal failure was the main toxicity in the phase II study and more frequent in older and those with baseline decrease in GFR. Grade 3-5 renal toxicity was observed in 16 of 74 patients (21%) treated at the phase II doses. Clofarabine melphalan alemtuzumab conditioning yields promising response and duration of response, but renal toxicity poses a considerable risk particularly in older patients.

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