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NCT02228096 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT02228096: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02228096 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02228096, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
This was a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or relapsed after allogeneic stem cell transplant.
Primary Outcome
ORR is defined as the percentage of participants with a best overall disease response of complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until the start of new anticancer therapy. Best response was assigned in the following order: CR, CRi, CR or CRi with residual mediastinal disease, No response and Unknown.
Interventions
- BIOLOGICAL CTL019 T-cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2014-08-14 |
| Est. Completion | 2019-05-24 |
| Phase | Phase 2 |
What the finished NCT02228096 record still lists
NCT02228096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 1 intervention - of which CTL019 T-cells is the first listed.
NCT02228096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02228096 about?
NCT02228096 is a clinical study titled "Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients". This was a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or relapsed after allogeneic stem...
What is the current status of trial NCT02228096?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2014-08-14. Estimated completion is 2019-05-24.
What interventions are being tested in trial NCT02228096?
The interventions under investigation include: CTL019 T-cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02228096?
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 NCT02228096's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 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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