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Clinical trial

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

NCT04094311 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Overall status
Recruiting
Start date
November 21, 2019
Completion date
March 31, 2027
Enrollment
200 (estimated)
Sites
55

Conditions

As the registry lists them; a condition with its own page is linked.

b-cell acute lymphoblastic leukemia, diffuse large b-cell lymphoma