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NCT03121677 · ClinicalTrials.gov registry record · Phase 1
Personalized Tumor Vaccine Strategy and PD-1 Blockade in Patients With Follicular Lymphoma
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT03121677: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT03121677 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03121677, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Follicular lymphoma (FL) has a number of effective standard of care therapies; however, FL is not currently considered curable. Therefore, designing well tolerated therapies without cumulative and long-term toxicity is critical. This is a pilot safety and feasibility study that combines a personalized tumor vaccine with nivolumab for the treatment of FL. Patients who demonstrate progression on this study may be treated with rituximab (or another monoclonal antibody against CD20) in addition to vaccine therapy with nivolumab at the discretion of treating physician if clinically indicated.
Primary Outcome
-Unacceptable toxicity will be described as inability to receive further therapy due to toxicities of therapy as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or the occurrence of other toxicities deemed to be at sufficiently high risk to patients by the principal investigator
Interventions
- BIOLOGICAL Nivolumab
- PROCEDURE Leukapheresis
- DRUG Poly ICLC
- PROCEDURE Peripheral blood draws
- BIOLOGICAL Personalized tumor vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2023-08-07 |
| Phase | Phase 1 |
Why NCT03121677 stopped before completion
NCT03121677 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT03121677 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03121677 about?
NCT03121677 is a clinical study titled "Personalized Tumor Vaccine Strategy and PD-1 Blockade in Patients With Follicular Lymphoma". Follicular lymphoma (FL) has a number of effective standard of care therapies; however, FL is not currently considered curable. Therefore, designing well tolerated therapies without cumulative and long-term toxicity is critical. This is a pilot safety and feasibility study that combines a personaliz...
What is the current status of trial NCT03121677?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2018-10-16. Estimated completion is 2023-08-07.
What interventions are being tested in trial NCT03121677?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Leukapheresis (PROCEDURE), Poly ICLC (DRUG), Peripheral blood draws (PROCEDURE), Personalized tumor vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03121677?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03121677's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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