Daratumumab for Relapsed/Refractory Lymphoma and Castleman Disease
This study is testing a drug called Daratumumab SC (daratumumab and hyaluronidase) for people with certain aggressive cancers: Primary Effusion Lymphoma (PEL), Plasmablastic Lymphoma (PBL), and Multicentric Castleman Disease (MCD). These diseases affect the immune system and lymph nodes and often don't respond well to standard treatments. Daratumumab SC is a monoclonal antibody, a type of drug that targets specific cells. You might be able to join if you are 18 or older and your cancer has come back, hasn't responded to previous treatment, or if you can't receive standard chemotherapy. The main goal is to see how many participants respond to the treatment. The current status of this study is unclear, and it plans to enroll 28 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is planned to enroll 28 participants.
- What's involved
- Participants will receive Daratumumab SC injections weekly for 8 weeks, then every two weeks for 16 weeks, and then every four weeks for up to 96 weeks. You will also have physical exams, blood tests, imaging scans, and heart and lung function tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured at 9 and 17 weeks, and then every 12 weeks from week 25 until the end of therapy.
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NCT05907759
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~28 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Daratumumab SC
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over at 9 and 17 weeks, and every 12 weeks from week 25 to the end of therapy
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Robert Yarchoan, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants with histologically confirmed primary effusion lymphoma (PEL) including extracavitary and KSHV-associated large cell lymphoma variants, plasmablastic lymphoma (PBL), and/or KSHV-associated multicentric Castleman disease (MCD) that has relapsed, and/or is refractory after frontline chemotherapy, or who are ineligible for front-line chemotherapy
Age \>= 18 years.
Any HIV status
Participants with HIV must be receiving or will initiate an effective combination antiretroviral therapy (ART) regimen and must have an undetectable HIV VL which is defined as \<200 copies/mL.
Participants with PEL or PBL must meet the following criteria:
Must have measurable or assessable lymphoma
ECOG performance status (PS) 0-2 or 3 if secondary to PEL or PBL
Adequate hematological and renal functions as defined below:
Hemoglobin (Hgb) \> 7 g/dL
Creatinine clearance (CrCl) \>= 15 mL/min/1.73 m\^2
Must have received first-line curative-intent therapy (anthracycline-containing chemotherapy) for PEL or PBL, unless such therapy is contraindicated due to infection that precludes combination chemotherapy (such as progressive multifocal leukoencephalopathy) or if there is a contraindication to receiving CHOP or EPOCH (such as multi-organ failure).
Participants with KSHV-MCD must meet the following criteria:
ECOG performance status (PS) 0-2 or 3 if secondary to MCD
Adequate hematological and renal functions as defined below:
Hemoglobin (Hgb) \> 7 g/dL
Creatinine clearance (CrCl) \>= 15 mL/min/1.73 m\^2
At least one clinical symptom attributed to KSHV-MCD
Fever (\>38 degrees Celsius)
Fatigue
Gastrointestinal symptoms
Respiratory/sinus symptoms
Rash
At least one laboratory abnormality attributed to KSHV-MCD
Anemia (Hgb \[men\] \< 12.5 g/dL, Hgb \[women\] \< 11 g/dL)
Thrombocytopenia (\< 150 K/microL)
Hypoalbuminemia (\< 3.4 g/dL)
Hyponatremia (\< 135 mmol/L)
Elevated C-reactive protein (CRP) (\> 3 mg/L)
For participants with evidence of chronic hepatitis B virus (HBV) infection, participants must be on suppressive therapy with an undetectable VL.
Participants who are seropositive for hepatitis C virus (HCV)are eligible only in the setting of a sustained virologic response \[SVR\], defined as aviremia, at least 12 weeks after completion of antiviral therapy.
Participants that have received investigational agents on other clinical trials must have had a washout period of 2 weeks or 5 drug half-lives, whichever is longer.
Women of child-bearing potential (WOCBP) must agree to use an effective (dual) form of contraception (barrier, surgical sterilization, abstinence) prior to study entry and for the duration of study participation and for 3 months after the last dose of study drug. WOCBP must refrain from egg donations during the study and for 3 months after the last dose of daratumumab.
Men must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 3 months after the last dose of the study drug(s). We also will recommend men with female partners of childbearing potential to ask female partners to be on an effective birth control (hormonal, intrauterine device \[IUD\], surgical sterilization).
Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 months after the last dose of the study drug.
Participants must understand and sign a written informed consent document.
Exclusion
Participants who have had anticancer treatment within the last 2 weeks unless the cancer treatment is for a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, such as local treatment for carcinoma in situ or hormonal therapy for prostate or breast carcinoma. Toxicity related to prior therapies other than hair loss and neuropathy must have resolved to grade 1.
KS requiring urgent treatment with cytotoxic chemotherapy.
Bilirubin (total) \> 1.5 times the upper limit of normal; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times the upper limit of normal (ULN);
Total bilirubin \>= 5 mg/dL in participants with Gilbert's syndrome as defined by \> 80% unconjugated
If the elevated total bilirubin or AST/ALT are due to ART or lymphoma
ANC \< 1000/mm\^3 and platelets \< 75,000/mm\^3 unless related to lymphoma and/or KSHV-MCD or prior therapy.
No life-threatening or organ-threatening manifestations of KSHV-MCD.
Clinically significant cardiac disease, including:
Myocardial infarction within 6 months of randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class IIIIV).
Uncontrolled cardiac arrhythmia
Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal.
Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.
Pregnant people as evaluated by a positive serum or urine beta-human chorionic gonadotropin (Beta-hCG) test
Participants with severe uncontrolled intercurrent illness, evaluated by history, physical exam and chemistry panel. Participants with severe intercurrent illnesses attributed to lymphoma may be eligible per PI s or designee s discretion.
What this trial measures
- Overall response rate (ORR)at 9 and 17 weeks, and every 12 weeks from week 25 to the end of therapy
Percentage of participants with the best overall response of CR or PR to therapy