Study Description
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. This is a single-arm, open-label, multicenter, interventional Phase IIIb study in pediatric/young adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (pALL) and adult patients with r/r large B-cell lymphoma (LBCL) including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B cell lymphoma, and DLBCL arising from follicular lymphoma for Part 1 and and r/r ALL and r/r non-Hodgkin's lymphomas (NHL) for Part 2
Patients whose final manufactured tisagenlecleucel patient-specific batch does not meet the approved local commercial release specifications are eligible for inclusion. Each case will be individually assessed and approved by the Novartis manufacturing facility and the Novartis global medical team (including Patient Safety). Following a single infusion of CTL019, the patient will be followed for 3 months for Part 1, and 1 day for Part 2.
Interventions
CTL019
Eligibility Criteria
Key inclusion criteria:
* 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.
Key exclusion criteria:
For part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:
* Human immunodeficience virus (HIV) positive patients.
* Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
* Patients with primary central nervous system (CNS) lymphoma.
* History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
* Uncontrolled active infection or inflammation.
* Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment.
* Pregnant or nursing (lactating) women. For part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of CTL019.
Novartis Investigative Site
Recruiting
Kanazawa,Ishikawa,920 8641,Japan
Novartis Investigative Site
Recruiting
Kyoto,606 8507,Japan
Novartis Investigative Site
Recruiting
Osaka Sayama,Osaka,589 8511,Japan
Novartis Investigative Site
Recruiting
Gifu-city,Gifu,501-1194,Japan
Novartis Investigative Site
Recruiting
Setagaya-ku,Tokyo,157-8535,Japan
Novartis Investigative Site
Recruiting
Nagasaki-city,Nagasaki,852-8501,Japan
Novartis Investigative Site
Recruiting
Bunkyo ku,Tokyo,113-8431,Japan
Novartis Investigative Site
Recruiting
Kita-gun,Kagawa,761-0793,Japan
Novartis Investigative Site
Recruiting
Niigata,951 8520,Japan
Novartis Investigative Site
Recruiting
Osaka-city,Osaka,541-8567,Japan
Novartis Investigative Site
Recruiting
Sapporo city,Hokkaido,060 8648,Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku,Tokyo,160 8582,Japan
Novartis Investigative Site
Recruiting
Yufu,Oita,879-5593,Japan
Novartis Investigative Site
Recruiting
Bunkyo ku,Tokyo,113-8677,Japan
Novartis Investigative Site
Recruiting
Yokohama-city,Kanagawa,236-0004,Japan
Novartis Investigative Site
Recruiting
Osaka,545-8586,Japan
Novartis Investigative Site
Recruiting
Osaka-city,Osaka,543-8555,Japan
Novartis Investigative Site
Recruiting
Aomori,030 8553,Japan
Novartis Investigative Site
Recruiting
Sapporo,Hokkaido,060-8543,Japan
Novartis Investigative Site
Recruiting
Kurashiki,Okayama,710-8602,Japan
Novartis Investigative Site
Recruiting
Bunkyo-ku,Tokyo,113-8519,Japan
Novartis Investigative Site
Recruiting
Nagoya-city,Aichi,467-8602,Japan
Novartis Investigative Site
Recruiting
Saitama,330 8777,Japan
Novartis Investigative Site
Recruiting
Kyoto-city,Kyoto,602-8566,Japan
Novartis Investigative Site
Recruiting
Suita,Osaka,565 0871,Japan
Novartis Investigative Site
Recruiting
Chiba,2608677,Japan
Novartis Investigative Site
Recruiting
Kobe,Hyogo,650-0047,Japan
Novartis Investigative Site
Recruiting
Okayama-city,Okayama,700-8558,Japan
Novartis Investigative Site
Recruiting
Chuo ku,Tokyo,104 0045,Japan
Novartis Investigative Site
Recruiting
Nagoya,Aichi,466 8560,Japan
Novartis Investigative Site
Recruiting
Wakayama,641-8510,Japan
Novartis Investigative Site
Recruiting
Tsu-city,Mie,514-8507,Japan
Novartis Investigative Site
Recruiting
Izumo-city,Shimane,693 8501,Japan
Novartis Investigative Site
Recruiting
Hiroshima,734-8551,Japan
Novartis Investigative Site
Recruiting
Nishinomiya,Hyogo,663 8501,Japan
Novartis Investigative Site
Recruiting
Izumi-city,Osaka,594-1101,Japan
Novartis Investigative Site
Recruiting
Fuchu,Tokyo,183-8524,Japan
Novartis Investigative Site
Recruiting
Toon city,Ehime,791-0295,Japan
Novartis Investigative Site
Recruiting
Sendai city,Miyagi,980 8574,Japan
Novartis Investigative Site
Recruiting
Hamamatsu,Shizuoka,431-3192,Japan
Novartis Investigative Site
Recruiting
Kumamoto,860-8556,Japan
Novartis Investigative Site
Recruiting
Tsukuba,Ibaraki,305-8576,Japan
Novartis Investigative Site
Recruiting
Izumisano-city,Osaka,598-8577,Japan
Novartis Investigative Site
Recruiting
Fukuoka city,Fukuoka,812-8582,Japan
Novartis Investigative Site
Recruiting
Minato-ku,Tokyo,105-8471,Japan
Novartis Investigative Site
Recruiting
Matsumoto,Nagano,390-8621,Japan
Novartis Investigative Site
Recruiting
Bunkyo ku,Tokyo,113 8655,Japan
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.