Study of Out of Specification for Tisagenlecleucel
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-100
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CTL019
Treatment groups
200 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov