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NCT03311958 · ClinicalTrials.gov registry record · Early Phase 1
Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance
A Early Phase 1 study of Diffuse Large B Cell Lymphoma, sponsored by Fox Chase Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03311958: Completed Early Phase 1 study of Diffuse Large B Cell Lymphoma, sponsored by Fox Chase Cancer Center.
NCT03311958 is a Early Phase 1 study of Diffuse Large B Cell Lymphoma that has completed, run by Fox Chase Cancer Center. The registered enrollment target is 15 participants, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03311958, a Early Phase 1 study of Diffuse Large B Cell Lymphoma, has completed, sponsored by Fox Chase Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients suffering from diffuse large B-cell lymphoma (DLBCL) who relapse within 12 months of chemotherapy usually undergo salvage therapies, followed by autologous transplant with a low success rate. These treatments for relapse have significant toxicities and may not be tolerated well by the patients. These patients need an effective means of identifying relapse at an early time point to be treated effectively. Detection of circulating tumor DNA (ctDNA) has been reported to be a sensitive and more specific method to detect relapse at an early stage compared to PET/ CT scans. Purpose of this trial is to monitor patients who have undergone successful chemotherapy for the presence of ctDNA. Patients who test positive for ctDNA would be treated with Nivolumab for a period of 2 years to avoid complete relapse.
Primary Outcome
Regular monitoring of ctDNA positive patients on nivolumab until they become ctDNA negative
Conditions Studied
Interventions
- DRUG Nivolumab, IV, 240 mg
Study Locations (1)
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2024-01-26 |
| Phase | Early Phase 1 |
What the finished NCT03311958 record still lists
NCT03311958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Nivolumab, IV, 240 mg is the first listed.
NCT03311958 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03311958 about?
NCT03311958 is a clinical study titled "Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance". Patients suffering from diffuse large B-cell lymphoma (DLBCL) who relapse within 12 months of chemotherapy usually undergo salvage therapies, followed by autologous transplant with a low success rate. These treatments for relapse have significant toxicities and may not be tolerated well by the patie...
What is the current status of trial NCT03311958?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2018-05-15. Estimated completion is 2024-01-26.
What conditions does trial NCT03311958 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT03311958?
The interventions under investigation include: Nivolumab, IV, 240 mg (DRUG).
Who is sponsoring clinical trial NCT03311958?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03311958 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03311958's enrollment target sits among peer trials
15 100th of 114 higher than 12 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma 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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