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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CTL019
Biological/VaccineA single intravenous (i.v.) infusion of CAR-positive viable T cells.
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Group A: pALLExperimental treatment 1 intervention
Group B: Group B: r/r LBCLExperimental treatment 1 intervention
Group C: Group C: r/r NHLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants with Adverse Events (AEs)
Percentage of participants with Serious AEs (SAEs) and non-SAEs
Time frame
From Screening up to 3 months for Part 1 and 1 day for Part 2Secondary outcomes
1
Part 1: Overall Remission Rate in Group A (pALL)
Overall Remission Rate is defined as the percentage of participants wiho achieve a complete remission (CR) and CR with incomplete blood count recovery (CRi) within 3 months following infusion of CTL019 as determined by the local investigator assessment for participants in group A (part 1).
Time frame
Up to 3 months2
Part 1: Overall Response Rate in Group B (LBCL)
ORR is defined as the percentage of patients who achieve a domplete response and partial response within 3 months following infusion of CTL019 as determined by the local investigator assessment for participants in group B (part 1).
Time frame
Up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov