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NCT07103486 · ClinicalTrials.gov registry record
A Study to Evaluate the Therapeutic Benefit of Tisagenlecleucel Compared to Existing Standard of Care in German Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 264
- Enrollment target
NCT07103486: Completed study, sponsored by Novartis Pharmaceuticals.
NCT07103486 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 264 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07103486 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 264 participants
- Enrollment target
Study Summary
The aim of this study was to evaluate the therapeutic benefit of tisagenlecleucel compared to the existing standard of care in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). For tisagenlecleucel patients, patient-level data from the JULIET study (CTL019C2201) was used. Data for patients treated with the appropriate comparator therapy (ACT) in German routine care was collected via chart review by 8 medical centers in Germany. The medical charts provided data on adult patients at the time of the qualifying treatments in the time period from approximately 2010 to 2017 with the longest possible follow-up phases (up to 5 years, but only until December 31, 2020).
Primary Outcome
For the external control and tisagenelcleucel FAS groups: OS was defined as the time from the date of treatment start to the date of death due to any cause and censored otherwise. For the tisagenelcleucel ITT group: OS was defined as the time from the date of enrollment to the date of death due to any cause and censored otherwise.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2023-01-31 |
What the finished NCT07103486 record still lists
NCT07103486 is an observational study that tracks outcomes without assigning an intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT07103486 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07103486 about?
NCT07103486 is a clinical study titled "A Study to Evaluate the Therapeutic Benefit of Tisagenlecleucel Compared to Existing Standard of Care in German Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma". The aim of this study was to evaluate the therapeutic benefit of tisagenlecleucel compared to the existing standard of care in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). For tisagenlecleucel patients, patient-level data from the JULIET study (CTL019C2201) w...
What is the current status of trial NCT07103486?
This trial is currently completed. The enrollment target is 264 participants. The study started on 2021-04-01. Estimated completion is 2023-01-31.
Who is sponsoring clinical trial NCT07103486?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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