RecruitingEarly Phase 1NCT04139304

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

A Multicenter, Open-Label Feasibility Study of Daratumumab With Dose-Adjusted EPOCH in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV


Sponsor

AIDS Malignancy Consortium

Enrollment

15 participants

Start Date

May 24, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of daratumumab (a targeted antibody drug) and a chemotherapy regimen called dose-adjusted EPOCH for a rare and aggressive blood cancer called plasmablastic lymphoma. **You may be eligible if...** - You have a confirmed diagnosis of plasmablastic lymphoma, stage II-IV (or stage I with elevated markers or a large tumor) - You are HIV-positive or HIV-negative (up to 7 HIV-negative patients will be enrolled) - If HIV-positive, your CD4 count is at least 100 cells/mL and you are on or willing to start effective HIV treatment (HAART) - Your blood counts and organ function are within acceptable levels - Your heart function (ejection fraction) is 45% or above - You agree to use effective contraception during and for 90 days after treatment **You may NOT be eligible if...** - You have had prior chemotherapy for this lymphoma (with limited exceptions) - You have previously received daratumumab - You have active hepatitis B or hepatitis C with cirrhosis - You have brain involvement from lymphoma - You are pregnant or breastfeeding - You have severe heart, lung, or other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Given IV

BIOLOGICALDaratumumab

Given IV

DRUGDoxorubicin

Given IV

DRUGDoxorubicin Hydrochloride

Given IV

DRUGEtoposide

Given IV

DRUGPrednisone

Given PO

DRUGVincristine

Given IV

DRUGVincristine Sulfate

Given IV


Locations(8)

University of Miami Miller School of Medicine

Miami, Florida, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04139304


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