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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Kaposi Sarcoma Herpesvirus;
B cell lymphoproliferative diseases;
Non-Hodgkin Lymphoma

Recruitment Keyword(s)



Lymphoma, Primary Effusion

Investigational Drug(s)

Daratumumab and hyaluronidase (daratumumab SC)

Investigational Device(s)



Drug: Daratumumab SC

Supporting Site

National Cancer Institute


Primary effusion lymphoma (PEL) is an aggressive form of cancer that affects cells in the immune system and lymph nodes. How PEL develops is not well understood, and this disease does not respond well to standard treatments for other types of lymphomas.


To test a drug treatment (daratumumab SC) in people with PEL.


People aged 18 and older with PEL. Their PEL must have failed to respond to therapy or they must be unable to receive standard treatment for the disease.


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.

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-Participants must have primary effusion lymphoma (PEL), including extracavitary variant and KSHV-associated large cell lymphoma and/or KSHV-associated multicentric Castleman disease pathologically that relapsed and/or is refractory after front-line chemotherapy or be ineligible for front-line chemotherapy. Note: Participants must have pathologic confirmation of the disease diagnosis (at any time) confirmed by NCI Laboratory of Pathology.

-Age >= 18 years.

-Any HIV status

-Those with HIV must have CD4 count >= 100 cells/microL or CD4 >= 50 cells/microL if CD4 was >= 100 cells/microL prior to front-line chemotherapy

-Participants with HIV must be receiving or willing to initiate an effective combination antiretroviral therapy (ART) regimen

-Participants with PEL must meet the following criteria:

--Must have measurable or assessable lymphoma

--ECOG performance status 0-2 or 3 if secondary to PEL

--Adequate hematological and renal functions as defined below:

---Hemoglobin (Hgb) > 7 g/dL

---Creatinine clearance (CrCl) >= 30 mL/min/1.73 m^2

--Must have received first-line curative-intent therapy (anthracycline-containing chemotherapy) for PEL, 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 0-2 or 3 if secondary to MCD

--Adequate hematological and renal functions as defined below:

---Hemoglobin (Hgb) > 7 g/dL

---Creatinine clearance (CrCl) >= 30 mL/min/1.73 m^2

--At least one clinical symptom attributed to KSHV-MCD

---Fever (>38 degrees Celsius)


---Gastrointestinal symptoms

---Respiratory/sinus symptoms


--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 viral load.

-Participants who are seropositive for hepatitis C 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 (WOBP) 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.

-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.


-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.

-Kaposi sarcoma requiring urgent treatment with cytotoxic chemotherapy.

-Bilirubin (total) > 1.5 times the upper limit of normal; AST and/or ALT > 3 times the upper limit of normal; 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-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.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Kathryn A. Lurain, M.D.
National Cancer Institute (NCI)
(301) 250-5156

Anaida Widell
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13C438
10 Center Drive
Bethesda, Maryland 20814
(240) 760-6074

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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