Study of Out of Specification for Tisagenlecleucel (NCT04094311)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Novartis Investigative Site — Hamilton, Ontario
Age range: 0 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (54 Sites)
Showing the first 25 of 54 sites.
- Novartis Investigative Site — Hamilton, Ontario
- Novartis Investigative Site — Ottawa, Ontario
- Novartis Investigative Site — Toronto, Ontario
- Novartis Investigative Site — Toronto, Ontario
- Novartis Investigative Site — Montreal, Quebec
- Novartis Investigative Site — Québec, Quebec
- Novartis Investigative Site — Nagoya, Aichi-ken
- Novartis Investigative Site — Nagoya, Aichi-ken
- Novartis Investigative Site — Tōon, Ehime
- Novartis Investigative Site — Gifu, Gifu
- Novartis Investigative Site — Sapporo, Hokkaido
- Novartis Investigative Site — Sapporo, Hokkaido
- Novartis Investigative Site — Kobe, Hyōgo
- Novartis Investigative Site — Nishinomiya, Hyōgo
- Novartis Investigative Site — Tsukuba, Ibaraki
- Novartis Investigative Site — Kita-gun, Kagawa-ken
- Novartis Investigative Site — Yokohama, Kanagawa
- Novartis Investigative Site — Kumamoto, Kumamoto
- Novartis Investigative Site — Kyoto, Kyoto
- Novartis Investigative Site — Tsu, Mie-ken
- Novartis Investigative Site — Sendai, Miyagi
- Novartis Investigative Site — Matsumoto, Nagano
- Novartis Investigative Site — Nagasaki, Nagasaki
- Novartis Investigative Site — Yufu, Oita Prefecture
- Novartis Investigative Site — Kurashiki, Okayama-ken
📞 Contact the Study Coordinator
Phone: +41613241111
Email: Novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.