RecruitingPhase 2NCT05907759

Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease

A Phase II Study of Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease


Sponsor

National Cancer Institute (NCI)

Enrollment

28 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Primary effusion lymphoma (PEL), plasmablastic lymphoma (PBL), and Multicentric Castleman Disease (MCD) are aggressive forms of cancer that affects cells in the immune system and lymph nodes. How they develop is not well understood, and these diseases do not respond well to standard treatments for other types of lymphomas. Objective: To test a drug treatment (daratumumab SC) in people with PEL, PBL, or MCD. Eligibility: People aged 18 and older with PEL, PBL, or MCD who must have failed to respond to therapy or they must be unable to receive standard treatment for the disease. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart and lung function. They may need to have a biopsy: tissue or fluid will be collected. They will have an eye exam. Daratumumab SC is given as an injection into the fat under the skin in the abdomen. This takes 3 to 5 minutes. Participants will receive the treatment once a week for 8 weeks; then every 2 weeks for 16 weeks; then every 4 weeks for up to 24 months. Participants will have other tests during the study period. These may include lumbar punctures: A needle will be inserted between the bones of the spine to draw some fluid from the area around the spinal cord. Participants may also have a thoracentesis: A needle or plastic tube will be inserted into the space around the lungs to withdraw fluid. Participants will have more imaging scans and blood tests. Follow-up visits will continue after treatment ends. Participants will be in the study for up to 5 years.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing daratumumab — a drug typically used in multiple myeloma — in people with rare blood cancers associated with a virus called KSHV (Kaposi sarcoma herpesvirus). These include primary effusion lymphoma (PEL), plasmablastic lymphoma (PBL), and KSHV-associated multicentric Castleman disease (MCD). **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of PEL, PBL, or KSHV-associated MCD - Your disease has returned after prior treatment, or you are not able to receive standard chemotherapy - You have adequate blood counts and kidney function - If you have HIV, you must be on effective treatment with an undetectable viral load **You may NOT be eligible if...** - You have had recent anti-cancer treatment within the past 2 weeks (with some exceptions) - You have significant liver problems (elevated bilirubin or liver enzymes beyond acceptable limits) - You have serious heart disease (recent heart attack, severe heart failure, or uncontrolled arrhythmia) - You have severe uncontrolled lung disease - You are pregnant 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

DRUGDaratumumab SC

Daratumumab SC (daratumumab and hyaluronidase) is administered subcutaneously (SC) as 1800 mg/30,000 units weekly for a total of 8 weeks (8 doses) followed by every 2 weeks for a total of 16 weeks (8 doses) followed by every 4 weeks for up to 96 weeks (24 doses)


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05907759