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Study of Out of Specification for Tisagenlecleucel
Sponsor: Novartis Pharmaceuticals
Summary
This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.
Official title: A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication
Key Details
Gender
All
Age Range
0 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2019-11-21
Completion Date
2027-03-31
Last Updated
2026-04-02
Healthy Volunteers
No
Interventions
CTL019
A single intravenous (i.v.) infusion of CAR-positive viable T cells.
Locations (53)
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Tōon, Ehime, Japan
Novartis Investigative Site
Gifu, Gifu, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Nishinomiya, Hyōgo, Japan
Novartis Investigative Site
Tsukuba, Ibaraki, Japan
Novartis Investigative Site
Kita-gun, Kagawa-ken, Japan
Novartis Investigative Site
Yokohama, Kanagawa-ku, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Tsu, Mie-ken, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Matsumoto, Nagano, Japan
Novartis Investigative Site
Nagasaki, Nagasaki, Japan
Novartis Investigative Site
Yufu, Oita Prefecture, Japan
Novartis Investigative Site
Kurashiki, Okayama-ken, Japan
Novartis Investigative Site
Izumi, Osaka, Japan
Novartis Investigative Site
Izumisano, Osaka, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Sakai, Osaka, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Izumo, Shimane, Japan
Novartis Investigative Site
Hamamatsu, Shizuoka, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Fuchū, Tokyo, Japan
Novartis Investigative Site
Minato-ku, Tokyo, Japan
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Aomori, Japan
Novartis Investigative Site
Chiba, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Hiroshima, Japan
Novartis Investigative Site
Ishikawa, Japan
Novartis Investigative Site
Kumamoto, Japan
Novartis Investigative Site
Kyoto, Japan
Novartis Investigative Site
Niigata, Japan
Novartis Investigative Site
Okayama, Japan
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Saitama, Japan
Novartis Investigative Site
Wakayama, Japan