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Study identifier: NCT04094311 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Study of Out of Specification for Tisagenlecleucel

Condition: B-cell Acute Lymphoblastic Leukemia · Diffuse Large B-cell Lymphoma  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 3
Planned participants200
Who can joinAll sexes, 0 Years to 100 Years
Healthy volunteersNo

About this study

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 description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals  ·  +41613241111  ·  Novartis.email@novartis.com

Novartis Pharmaceuticals  ·  +81337978748  ·  Novartis.email@novartis.com

Always discuss trial participation with your own doctor first.

Locations (54)

Novartis Investigative SiteHamilton, Ontario, CanadaCompleted
Novartis Investigative SiteOttawa, Ontario, CanadaWithdrawn
Novartis Investigative SiteToronto, Ontario, CanadaCompleted
Novartis Investigative SiteToronto, Ontario, CanadaCompleted
Novartis Investigative SiteMontreal, Quebec, CanadaWithdrawn
Novartis Investigative SiteQuébec, Quebec, CanadaWithdrawn
Novartis Investigative SiteNagoya, Aichi-ken, JapanRecruiting
Novartis Investigative SiteNagoya, Aichi-ken, JapanRecruiting
Novartis Investigative SiteTōon, Ehime, JapanRecruiting
Novartis Investigative SiteGifu, Gifu, JapanRecruiting
Novartis Investigative SiteSapporo, Hokkaido, JapanRecruiting
Novartis Investigative SiteSapporo, Hokkaido, JapanRecruiting

+ 42 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04094311