Phase II trial of zanolimumab (HuMax-CD4) in relapsed or refractory non-cutaneous peripheral T-cell lymphoma
Résumé
Purpose To explore efficacy and safety of zanolimumab (HuMax-CD4) in patients with relapsed or refractory peripheral T cell lymphoma (PTCL). Patients and Methods Twenty-one adult patients with relapsed or refractory CD4+ PTCL of non-cutaneous type (angioimmunoblastic T-cell lymphoma (AITL) n=9, PTCL-not otherwise specified (NOS) n=7, anaplastic large cell lymphoma (ALCL) n=4 and enteropathy type T-cell lymphoma n=1) were treated in a single-arm multi-center study, with weekly intravenous infusions of zanolimumab 980 mg for 12 weeks. Median age was 69 years (range 26-85). Seventeen of the patients had advanced stage disease (Ann Arbor stages III-IV). Results Objective tumor responses were obtained in 24% of the patients with 2 complete responses unconfirmed (CRu) and 3 partial responses (PR). One of the CRus lasted more than 252 days. Responses were obtained in different PTCL entities: AITL (n=3), ALCL (n=1) and PTCL-NOS (n=1). In general, the trial drug was well tolerated with no major toxicity. No infections related to the trial drug were reported. Conclusion Zanolimumab at a dose of 980 mg weekly demonstrated clinical activity and an acceptable safety profile in this poor-prognosis patient population, suggesting that the potential benefit combining zanolimumab with standard chemotherapy in the treatment of PTCL should be investigated.
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