Study of Out of Specification for Tisagenlecleucel
Recruiting
Phase 3
Interventional Study
B-cell Acute Lymphoblastic Leukemia
Diffuse Large B-cell Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 – 100
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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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.
Trial Locations
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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 t…
Contacts