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New treatment option for Lymphoma, Primary Effusion
Official title Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
ClinicalTrials.gov ID: NCT05907759
What this study is testing
What is Daratumumab SC?
Daratumumab SC is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for lymphoma, primary effusion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants with histologically confirmed primary effusion lymphoma (PEL) including extracavitary and KSHV-associated large cell lymphoma variants...
- 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...
- Participants with PEL or PBL must meet the following criteria:
You likely can't join if
- Participants who have had anticancer treatment within the last 2 weeks unless the cancer treatment is for a malignancy whose natural history or...
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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 how...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.