Daratumumab for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have been on investigational agents from other clinical trials, a washout period (time without taking certain medications) of 2 weeks or 5 drug half-lives is required, whichever is longer.
What safety data exists for Daratumumab in humans?
How does the drug Daratumumab SC differ from other treatments for lymphoma?
Daratumumab SC is unique because it is administered subcutaneously (under the skin), which can be more convenient and faster than intravenous (into the vein) treatments like Rituximab, commonly used for lymphoma. Additionally, Daratumumab targets a different protein, CD38, compared to Rituximab, which targets CD20, offering a novel mechanism of action for treating lymphoma.678910
Who Is on the Research Team?
Robert Yarchoan, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults with Primary Effusion Lymphoma (PEL) that's resistant to standard treatment or those who can't receive it. Eligible participants include any HIV status, but if positive, they must have a certain CD4 count and be on effective antiretroviral therapy. They should have adequate blood and kidney function, not be pregnant, agree to contraception use during the study, and sign consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Daratumumab SC is administered weekly for 8 weeks, then every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab SC
Daratumumab SC is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor