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Study of Out of Specification for Tisagenlecleucel

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma

Interventions: CTL019

Countries: Canada, Japan

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 overview

Sex: ALL

Age: 0 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (54)

Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Tōon, Ehime, Japan
Gifu, Gifu, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Tsukuba, Ibaraki, Japan
Kita-gun, Kagawa-ken, Japan
Yokohama, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Kyoto, Kyoto, Japan
Tsu, Mie-ken, Japan
Sendai, Miyagi, Japan
Matsumoto, Nagano, Japan
Nagasaki, Nagasaki, Japan
Yufu, Oita Prefecture, Japan
Kurashiki, Okayama-ken, Japan
Izumi, Osaka, Japan
Izumisano, Osaka, Japan
Osaka, Osaka, Japan
Sakai, Osaka, Japan
Suita, Osaka, Japan
+ 24 more on CT.gov