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NCT02435849 · 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
- 80
- Enrollment target
NCT02435849: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02435849 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02435849, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r/r B-cell ALL.
Primary Outcome
Evaluating the efficacy of tisagenlecleucel therapy from all manufacturing facilities as measured by overall remission rate (ORR) during the 3 months after tisagenlecleucel administration. ORR included complete response (CR) and CR with incomplete blood count recovery (CRi) as determined by an Independent Review Committee assessment. Per response criteria defined by National Comprehensive Cancer Network (NCCN), American Society of Hematology (ASH) and International Working Group (IWG) guidelines
Interventions
- BIOLOGICAL CTL019
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2015-04-08 |
| Est. Completion | 2022-11-17 |
| Phase | Phase 2 |
What the finished NCT02435849 record still lists
NCT02435849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which CTL019 is the first listed.
NCT02435849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02435849 about?
NCT02435849 is a clinical study titled "Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients". This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r/r B-cell ALL.
What is the current status of trial NCT02435849?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2015-04-08. Estimated completion is 2022-11-17.
What interventions are being tested in trial NCT02435849?
The interventions under investigation include: CTL019 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02435849?
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 NCT02435849's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 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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