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NCT02445248 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients
A Phase 2 study of Diffuse Large B Cell Lymphoma (DLBCL), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
- 20
- Study locations
NCT02445248: Completed Phase 2 study of Diffuse Large B Cell Lymphoma (DLBCL), sponsored by Novartis Pharmaceuticals.
NCT02445248 is a Phase 2 study of Diffuse Large B Cell Lymphoma (DLBCL) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 115 participants, below the 251-participant average among 10 other Diffuse Large B Cell Lymphoma (DLBCL) trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02445248, a Phase 2 study of Diffuse Large B Cell Lymphoma (DLBCL), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.
Primary Outcome
ORR, which includes complete response (CR) and partial response (PR) in the Main cohort as determined by IRC assessment. ORR is the percentage of participants with a best overall disease response of CR or PR, where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until progressive disease or start of new anticancer therapy (including ASCT), whichever comes first. Response was assessed according to Evaluation Criteria in diffuse large B cell
Conditions Studied
Interventions
- DRUG Lymphodepleting chemotherapy
- BIOLOGICAL Tisagenlecleucel
Study Locations (20)
Other
- Novartis Investigative Site - Camperdown
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Pierre-Bénite
- Novartis Investigative Site - Würzburg
California
- UCSF Medical Center . - San Francisco
Georgia
- Emory University School of Medicine/Winship Cancer Institute SC CTL019 - Atlanta
Illinois
- University of Chicago Medical Center Hematology and Oncology SC - CTL019B2207J - Chicago
Kansas
- University of Kansas Cancer Center SC - CTL019C2201 - Westwood
Maryland
- Sidney Kimmel Comprehensive Cancer Center SC-2 - Baltimore
Michigan
- Uni of Michigan Health System SC CTL019 - Ann Arbor
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2015-07-29 |
| Est. Completion | 2022-12-22 |
| Phase | Phase 2 |
What the finished NCT02445248 record still lists
NCT02445248 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 251-participant average among 10 other Diffuse Large B Cell Lymphoma (DLBCL) trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma (DLBCL) appearing as the primary indexed condition, and to 2 interventions - of which Lymphodepleting chemotherapy is the first listed.
NCT02445248 names 20 study sites across 17 states, led by Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02445248 about?
NCT02445248 is a clinical study titled "Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients". This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.
What is the current status of trial NCT02445248?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2015-07-29. Estimated completion is 2022-12-22.
What conditions does trial NCT02445248 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma (DLBCL).
What interventions are being tested in trial NCT02445248?
The interventions under investigation include: Lymphodepleting chemotherapy (DRUG), Tisagenlecleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT02445248?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02445248 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diffuse Large B Cell Lymphoma (DLBCL)
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Where NCT02445248's enrollment target sits among peer trials
115 6th of 10 higher than 5 of 10 other Diffuse Large B Cell Lymphoma (DLBCL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma (DLBCL) 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.
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