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NCT04139304 · ClinicalTrials.gov registry record · Early Phase 1

A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma

A Early Phase 1 study of Plasmablastic Lymphoma and Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, sponsored by AIDS Malignancy Consortium.

Recruiting
Registry status
Early Phase 1
Development phase
15
Enrollment target
8
Study locations

NCT04139304 is a Early Phase 1 study of Plasmablastic Lymphoma and Ann Arbor Stage II Diffuse Large B-Cell Lymphoma that is actively recruiting participants, run by AIDS Malignancy Consortium. The registered enrollment target is 15 participants, below the 79-participant average among 3 other Plasmablastic Lymphoma trials with a reported enrollment target (81% lower). The trial reports 8 study locations across 8 states.

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The verdict

NCT04139304, a Early Phase 1 study of Plasmablastic Lymphoma and Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, is actively recruiting participants, sponsored by AIDS Malignancy Consortium.

RECRUITING
Registry status
Early Phase 1
Development phase
15 participants
Enrollment target
8
Study locations

Study Summary

This feasibility trial studies how well daratumumab in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-EPOCH) works in treating patients with newly diagnosed stage I-IV plasmablastic lymphoma. Plasmablastic lymphoma cells have high levels of a protein called CD38. Daratumumab is a monoclonal antibody that specifically targets CD38 expressing cells, and may help the body's immune system attack the cancer and interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab may enhance the effectiveness of a standard chemotherapy (DA-EPOCH) in patients with plasmablastic lymphoma.

Conditions Studied

Plasmablastic Lymphoma Ann Arbor Stage II Diffuse Large B-Cell Lymphoma Ann Arbor Stage III Diffuse Large B-Cell Lymphoma Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma Ann Arbor Stage I Diffuse Large B-Cell Lymphoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin
  • DRUG Doxorubicin Hydrochloride
  • DRUG Etoposide
  • BIOLOGICAL Daratumumab

Study Locations (8)

Florida

  • University of Miami Miller School of Medicine - Miami

Illinois

  • University of Illinois at Chicago - Chicago

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore

New York

  • Memorial Sloan Kettering Cancer Center - New York

North Carolina

  • University of North Carolina - Chapel Hill - Chapel Hill

Ohio

  • The Ohio State University - Columbus

Pennsylvania

  • University of Pennsylvania - Philadelphia

Texas

  • The University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-05-24
Est. Completion 2030-07
Phase Early Phase 1

Sponsor

AIDS Malignancy Consortium

45 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04139304

The ClinicalTrials.gov registry entry for NCT04139304 describes a study currently listed as recruiting, 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 79-participant average among 3 other Plasmablastic Lymphoma trials with a reported enrollment target (81% lower). The listed sponsor is AIDS Malignancy Consortium, which has 45 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Plasmablastic Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT04139304 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Florida, Illinois, Maryland.

Frequently Asked Questions

What is clinical trial NCT04139304 about?

NCT04139304 is a clinical study titled "A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma". This feasibility trial studies how well daratumumab in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-EPOCH) works in treating patients with newly diagnosed stage I-IV plasmablastic lymphoma. Plasmablastic lymphoma cells...

What is the current status of trial NCT04139304?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2021-05-24. Estimated completion is 2030-07.

What conditions does trial NCT04139304 study?

This clinical trial studies the following conditions: Plasmablastic Lymphoma, Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma.

What interventions are being tested in trial NCT04139304?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Daratumumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04139304?

This trial is sponsored by AIDS Malignancy Consortium, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04139304 being conducted?

This trial has 8 study locations across Florida, Illinois, Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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