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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 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.

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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.

Interventions

  • BIOLOGICAL Nivolumab

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-04-26
Est. Completion 2031-06-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03258567

The ClinicalTrials.gov registry entry for NCT03258567 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (92% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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