Phase I and Pharmacokinetic Study of Inotuzumab Ozogamicin (CMC- 544) as a Single Agent in Japanese Patients with Follicular Lymphoma Pretreated with Rituximab.

Autor: Tobinai, Kensei, Ogura, Michinori, Hatake, Kiyohiko, Kobayashi, Yukio, Watanabe, Takashi, Uchida, Toshiki, Kasai, Masanobu, Yokoyama, Masahiro, Terui, Yasuhito, Ono, Chiho, Akiyama, Masanao, Ohata, Junko
Zdroj: Blood; November 2008, Vol. 112 Issue: 11 p1565-1565, 1p
Abstrakt: Introduction: Inotuzumab ozogamicin (CMC-544) is an antibody-targeted chemotherapeutic agent composed of a monoclonal antibody which targets the CD22 antigen, conjugated to calicheamicin, a potent cytotoxic antitumor antibiotic. Since CD22 is expressed on more than 90% of B-lymphoid malignancies, CMC-544 may be useful for treating patients (pts) with B-cell non-Hodgkin lymphoma (B-NHL). In a phase I study in the US and EU, CMC-544 showed definite clinical activity in pts with relapsed/refractory B-NHL (both follicular and diffuse large) with clinically manageable thrombocytopenia as the main toxicity. In this phase 1 study, the safety, tolerability, efficacy and pharmacokinetics (PK) of CMC-544 was evaluated in Japanese pts with relapsed or refractory B-cell NHL.
Databáze: Supplemental Index