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
Who is this study for? Children and adult patients with diffuse large B-cell lymphoma and leukemia
What treatments are being studied? Tisagenlecleucel
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Maximum Age: 100
Healthy Volunteers: f
View:
• Signed informed consent/assent must be obtained for this study prior to participation in the study.
• Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.
• Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country/region.
• OOS material has not been deemed to pose an undue safety risk to the patient.
• Patient is suffering from a serious or life-threatening disease or condition.
• Repeat leukapheresis is not clinically appropriate per the investigator assessment.
Locations
Other Locations
Canada
Novartis Investigative Site
COMPLETED
Hamilton
Novartis Investigative Site
WITHDRAWN
Montreal
Novartis Investigative Site
WITHDRAWN
Ottawa
Novartis Investigative Site
WITHDRAWN
Québec
Novartis Investigative Site
COMPLETED
Toronto
Novartis Investigative Site
COMPLETED
Toronto
Japan
Novartis Investigative Site
RECRUITING
Aomori
Novartis Investigative Site
RECRUITING
Bunkyo Ku
Novartis Investigative Site
RECRUITING
Bunkyo Ku
Novartis Investigative Site
RECRUITING
Bunkyo Ku
Novartis Investigative Site
RECRUITING
Bunkyo-ku
Novartis Investigative Site
RECRUITING
Chiba
Novartis Investigative Site
RECRUITING
Chuo Ku
Novartis Investigative Site
RECRUITING
Fuchū
Novartis Investigative Site
RECRUITING
Fukuoka
Novartis Investigative Site
RECRUITING
Gifu
Novartis Investigative Site
RECRUITING
Hamamatsu
Novartis Investigative Site
RECRUITING
Hiroshima
Novartis Investigative Site
RECRUITING
Izumi
Novartis Investigative Site
RECRUITING
Izumisano
Novartis Investigative Site
RECRUITING
Izumo
Novartis Investigative Site
RECRUITING
Kanazawa
Novartis Investigative Site
RECRUITING
Kita-gun
Novartis Investigative Site
RECRUITING
Kobe
Novartis Investigative Site
RECRUITING
Kumamoto
Novartis Investigative Site
RECRUITING
Kurashiki
Novartis Investigative Site
RECRUITING
Kyoto
Novartis Investigative Site
RECRUITING
Kyoto
Novartis Investigative Site
RECRUITING
Matsumoto
Novartis Investigative Site
RECRUITING
Minato-ku
Novartis Investigative Site
RECRUITING
Nagasaki
Novartis Investigative Site
RECRUITING
Nagoya
Novartis Investigative Site
RECRUITING
Nagoya
Novartis Investigative Site
RECRUITING
Niigata
Novartis Investigative Site
RECRUITING
Nishinomiya
Novartis Investigative Site
RECRUITING
Okayama
Novartis Investigative Site
RECRUITING
Osaka
Novartis Investigative Site
RECRUITING
Osaka
Novartis Investigative Site
RECRUITING
Osaka
Novartis Investigative Site
RECRUITING
Ōsaka-sayama
Novartis Investigative Site
RECRUITING
Saitama
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Sendai
Novartis Investigative Site
RECRUITING
Setagaya-ku
Novartis Investigative Site
RECRUITING
Shinjuku-ku
Novartis Investigative Site
RECRUITING
Suita
Novartis Investigative Site
RECRUITING
Tōon
Novartis Investigative Site
RECRUITING
Tsu
Novartis Investigative Site
RECRUITING
Tsukuba
Novartis Investigative Site
RECRUITING
Wakayama
Novartis Investigative Site
RECRUITING
Yokohama
Novartis Investigative Site
RECRUITING
Yufu
Contact Information
Primary
Novartis Pharmaceuticals
Novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
+81337978748
Time Frame
Start Date: 2019-11-21
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 200
Treatments
Experimental: Group A: pALL
Pediatric/young adult patients with r/r pALL who meet the indication in the Health Authority-approved CTL019 package insert in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.
Experimental: Group B: r/r LBCL
Adult patients with r/r LBCL including DLBCL not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, that is consistent with the Health Authority-approved indication in the package insert for CTL019 in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.
Experimental: Group C: r/r NHL
Adult patients with r/r NHL in consistent with the Health Authority approved indication in the package insert for CTL019 in Japan whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals