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

Q: Who can participate in NCT05907759?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT05907759?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease (NCT05907759) is a Phase 2 interventional studying Lymphoma, Primary Effusion, sponsored by National Cancer Institute (NCI). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About 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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Lymphoma, Primary Effusion and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 28 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

* Who May Qualify: - Participants with diagnosed by tissue sample (biopsy-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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

* INCLUSION CRITERIA: * 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 CRITERIA: * 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); EXCEPTIONS: * 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.

Treatments Being Tested

DRUG

Daratumumab 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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05907759), the sponsor (National Cancer Institute (NCI)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05907759 clinical trial studying?

Who can participate in NCT05907759?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05907759?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05907759. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05907759. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.