Study of Out of Specification for Tisagenlecleucel

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.

Trial Details

NCT ID
NCT04094311
Phase
PHASE3
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • CTL019
Locations (sample)
  • Hamilton, Ontario, Canada|43.25011,-79.84963
  • Toronto, Ontario, Canada|43.70643,-79.39864
  • Montreal, Quebec, Canada|45.50884,-73.58781
  • Nagoya, Aichi-ken, Japan|35.18147,136.90641
  • Tōon, Ehime, Japan|33.79427,132.89011

Key Eligibility 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 countr…
  • OOS material has not been deemed to pose an undue safety risk to the patient.

For full eligibility, visit ClinicalTrials.gov.

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