Study of Out of Specification for Tisagenlecleucel
NCT04094311Phase 3Recruiting
- Lead sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 200 (estimated)
- Start date
- 21 Nov 2019
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027
- Last update posted
- 15 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None
- Arms
- 3
Interventions
- CTL019 Biological
Conditions and primary outcome
- B-cell Acute Lymphoblastic Leukemia
- Diffuse Large B-cell Lymphoma
Primary outcome
Percentage of participants with Adverse Events (AEs) (From Screening up to 3 months for Part 1 and 1 day for Part 2)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT04094311.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04094311 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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