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NCT04094311 · ClinicalTrials.gov record · last posted 2026-06-25

Study of Out of Specification for Tisagenlecleucel

StatusRecruiting
PhasePhase 3
Started2019-11-21
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 44 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 44 times since 2019-09-16; most recent amendment 2026-06-24. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2020-02-07
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT04094311
Lead Sponsor Novartis Pharmaceuticals
Conditions B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma
Enrollment 200 participants
Start Date 2019-11-21
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-25