# Study of Out of Specification for Tisagenlecleucel

Source: https://onco.cc/trials/nct04094311/  
OnCo record `nct04094311` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Tisagenlecleucel in diffuse large b-cell lymphoma, run by Novartis Pharmaceuticals, now recruiting.

## Summary

Study of Out of Specification for Tisagenlecleucel is a phase 3 interventional study registered as NCT04094311 by Novartis Pharmaceuticals, with 200 participants planned, started 2019-11-21 and due to reach its primary completion in 2027-03-31. Interventions recorded: CTL019. Conditions listed: B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT04094311
- Phase: 3
- Setting: A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication
- Sponsor: Novartis Pharmaceuticals
- Enrolled: 200

## Sources

- ClinicalTrials.gov NCT04094311: https://clinicaltrials.gov/study/NCT04094311

## Connected records

- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/)
- drugs: [Tisagenlecleucel](https://onco.cc/drugs/tisagenlecleucel/)
- companies: [Novartis](https://onco.cc/companies/novartis/)

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JSON: https://onco.cc/api/v1/entities/nct04094311.json