A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Summary

The primary objective of this study is to confirm the safety profile of alemtuzumab 30 mg (the US/European Union (EU) approved dose) in Japanese patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).

Timeline

Start

2010-02

Primary completion

2011-08

Completion

2011-08

Publications

• Ishizawa K, Fukuhara N, Nakaseko C, Chiba S, Ogura M, Okamoto A, Sunaga Y, Tobinai K. Safety, efficacy and pharmacokinetics of humanized anti-CD52 monoclonal antibody alemtuzumab in Japanese patients with relapsed or refractory B-cell chronic lymphocytic leukemia. Jpn J Clin Oncol. 2017 Jan;47(1):54-60. doi: 10.1093/jjco/hyw146. Epub 2016 Oct 7.

Drugs

Indications