RecruitingPhase 3NCT04094311

Study of Out of Specification for Tisagenlecleucel

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

Sponsor

Novartis Pharmaceuticals

Enrollment

200 participants

Start Date

Nov 21, 2019

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia

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.

Eligibility

Min Age: 0 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study provides access to tisagenlecleucel — a type of CAR T-cell therapy (an immune cell treatment engineered to fight cancer) — for patients whose manufactured batch did not meet standard release criteria. It allows these patients to still receive the treatment under careful supervision rather than being denied access. **You may be eligible if...** - Your manufactured tisagenlecleucel product did not meet the commercial release specifications - You have a serious or life-threatening cancer for which this therapy is intended - Collecting another batch of cells (repeat leukapheresis) is not medically appropriate for you **You may NOT be eligible if...** - You are HIV positive - You have active Hepatitis B or Hepatitis C - You have primary central nervous system (CNS) lymphoma - You have an uncontrolled active infection or inflammation - You are pregnant or breastfeeding - You have known allergies to drugs similar to tisagenlecleucel Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCTL019

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

View Full Details on ClinicalTrials.gov

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NCT04094311

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