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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 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.

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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.

Interventions

  • DRUG Nivolumab, IV, 240 mg

Study Locations (1)

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2018-05-15
Est. Completion 2024-01-26
Phase Early Phase 1

Sponsor

Fox Chase Cancer Center

183 total trials

What the Registry Record Tells You About NCT03311958

The ClinicalTrials.gov registry entry for NCT03311958 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (93% lower). The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.

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

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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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