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NCT03258567 · ClinicalTrials.gov registry record · Phase 2
Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas
A Phase 2 study of Lymphoma and Lymphoproliferative Disorder, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03258567: Recruiting Phase 2 study of Lymphoma and Lymphoproliferative Disorder, sponsored by National Cancer Institute (NCI).
NCT03258567 is a Phase 2 study of Lymphoma and Lymphoproliferative Disorder that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03258567, a Phase 2 study of Lymphoma and Lymphoproliferative Disorder, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments. Objectives: To see if Nivolumab slows the growth of some types of cancer or stops them from getting worse. To test the safety of the drug. Eligibility: People 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders or EBV-positive non-Hodgkin lymphomas with no standard therapy Design: Participants will be screened with: Medical history Physical exam Blood and urine tests CAT scan of the chest, abdomen, and pelvis Tumor and bone marrow biopsies (sample taken) Magnetic resonance imaging scan of the brain Lumbar puncture (also known as spinal tap) Positron emission tomography/computed tomography scan with a radioactive tracer Every 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also have: Physical exam Blood and pregnancy tests Review of side effects and medications During the study, participants will repeat most of the screening tests. They may also have other biopsies. After stopping treatment, participants will have a visit every 3 months for 1 year. Then they will have a visit every 6 months for years 2-5, and then once a year. They will have a physical exam and blood tests.
Primary Outcome
number of patients who respond to the protocol therapy (CR, PR, SD)
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-04-26 |
| Est. Completion | 2031-06-01 |
| Phase | Phase 2 |
What NCT03258567 shows while recruiting
NCT03258567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Nivolumab is the first listed.
NCT03258567 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03258567 about?
NCT03258567 is a clinical study titled "Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas". Background: The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments. Objectives: To see if Nivolumab slows the growth o...
What is the current status of trial NCT03258567?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-04-26. Estimated completion is 2031-06-01.
What conditions does trial NCT03258567 study?
This clinical trial studies the following conditions: Lymphoma, Lymphoproliferative Disorder, Epstein-Barr Virus Infections, Disorders, Lymphoproliferative.
What interventions are being tested in trial NCT03258567?
The interventions under investigation include: Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03258567?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03258567 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03258567's enrollment target sits among peer trials
40 174th of 299 higher than 116 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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