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NCT03610724 · ClinicalTrials.gov registry record · Phase 2
Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT03610724 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 34 participants.
The verdict
NCT03610724, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of the study was to assess the efficacy and safety of tisagenlecleucel in pediatric, adolescent and young adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) including Burkitt Lymphoma and Burkitt Leukemia. For pediatric patients who have r/r B-NHL including Burkitt Lymphoma and Burkitt Leukemia, survival rates are dismal, only \~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.
Interventions
- DRUG Bridging Therapy
- BIOLOGICAL Tisagenlecleucel
- DRUG lymphodepleting chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-02-15 |
| Est. Completion | 2023-04-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03610724
The ClinicalTrials.gov registry entry for NCT03610724 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bridging Therapy is the first listed.
NCT03610724 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03610724 about?
NCT03610724 is a clinical study titled "Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients". The purpose of the study was to assess the efficacy and safety of tisagenlecleucel in pediatric, adolescent and young adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) including Burkitt Lymphoma and Burkitt Leukemia. For pediatric patients who have r/r B-NHL including ...
What is the current status of trial NCT03610724?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2019-02-15. Estimated completion is 2023-04-26.
What interventions are being tested in trial NCT03610724?
The interventions under investigation include: Bridging Therapy (DRUG), Tisagenlecleucel (BIOLOGICAL), lymphodepleting chemotherapy (DRUG).
Who is sponsoring clinical trial NCT03610724?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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