Actively Recruiting
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
Led by National Cancer Institute (NCI) · Updated on 2026-05-01
28
Participants Needed
1
Research Sites
594 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary effusion lymphoma (including extracavitary and KSHV-associated large cell lymphoma variants), plasmablastic lymphoma, and/or KSHV-associated multicentric Castleman disease that has relapsed or is refractory after frontline chemotherapy, or ineligible for frontline chemotherapy
- Age 18 years or older
- Any HIV status; HIV-positive participants must be on effective antiretroviral therapy with undetectable viral load (<200 copies/mL)
- For PEL or PBL: measurable or assessable disease, ECOG performance status 0-2 (or 3 if due to lymphoma), adequate blood and kidney function (hemoglobin >7 g/dL, creatinine clearance ≥15 mL/min/1.73 m2), and prior first-line curative therapy unless contraindicated
- For KSHV-MCD: ECOG performance status 0-2 (or 3 if due to MCD), adequate blood and kidney function (hemoglobin >7 g/dL, creatinine clearance ≥15 mL/min/1.73 m2), at least one clinical symptom (fever, fatigue, gastrointestinal or respiratory symptoms, rash), and at least one laboratory abnormality (anemia, low platelets, low albumin, low sodium, or elevated C-reactive protein)
- Participants with chronic hepatitis B must be on suppressive therapy with undetectable viral load
- Participants with hepatitis C must have sustained virologic response after antiviral therapy
- Washout period of at least 2 weeks or 5 drug half-lives from prior investigational treatments
- Women of childbearing potential and men must agree to use effective contraception during and for 3 months after treatment
- Willingness to discontinue breastfeeding during treatment and for 3 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Recent anticancer treatment within 2 weeks unless for malignancies unlikely to interfere with study treatment assessment
- Kaposi sarcoma requiring urgent chemotherapy
- Elevated bilirubin (>1.5 times upper limit of normal) or liver enzymes AST/ALT (>3 times upper limit) except in defined exceptions
- Low neutrophil count (<1000/mm3) and low platelets (<75,000/mm3) unless related to lymphoma, KSHV-MCD, or prior therapy
- Life-threatening or organ-threatening KSHV-MCD manifestations
- Significant cardiac disease including recent myocardial infarction, unstable angina, congestive heart failure (NYHA Class III-IV), uncontrolled arrhythmia
- Severe lung disease such as COPD with FEV1 <50% predicted or moderate/severe persistent asthma within past 2 years
- Pregnancy detected by positive beta-hCG test
- Severe uncontrolled illnesses not related to lymphoma unless approved by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Anaida Widell
CONTACT
R
Robert Yarchoan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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