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NCT03568461 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT03568461: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03568461 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03568461, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
Primary Outcome
Complete response rate was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) recorded from tisagenlecleucel infusion until progressive disease or start of new anticancer therapy, whichever came first. CRR was determined by an independent review committee (IRC) and was based on Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is b
Interventions
- BIOLOGICAL tisagenlecleucel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2018-11-12 |
| Est. Completion | 2025-05-28 |
| Phase | Phase 2 |
What the finished NCT03568461 record still lists
NCT03568461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 1 intervention - of which tisagenlecleucel is the first listed.
NCT03568461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03568461 about?
NCT03568461 is a clinical study titled "Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma". This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
What is the current status of trial NCT03568461?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2018-11-12. Estimated completion is 2025-05-28.
What interventions are being tested in trial NCT03568461?
The interventions under investigation include: tisagenlecleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT03568461?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03568461's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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