OncoMatch/Clinical Trials/NCT05907759
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
Official title: A Phase II Study of Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
Is NCT05907759 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Daratumumab SC for lymphoma, primary effusion.
Treatment: Daratumumab SC — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: anthracycline-containing chemotherapy — first-line curative-intent therapy for PEL or PBL
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).
Lab requirements
Blood counts
Hemoglobin (Hgb) > 7 g/dL; ANC ≥ 1000/mm^3 and platelets ≥ 75,000/mm^3 unless related to lymphoma and/or KSHV-MCD or prior therapy
Kidney function
Creatinine clearance (CrCl) ≥ 15 mL/min/1.73 m^2
Liver function
Bilirubin (total) ≤ 1.5x ULN (exceptions: total bilirubin ≥ 5 mg/dL in Gilbert's syndrome as defined by >80% unconjugated; if elevated total bilirubin or AST/ALT are due to ART or lymphoma); AST/ALT ≤ 3x ULN (exceptions: if due to ART or lymphoma)
Adequate hematological and renal functions as defined below: Hemoglobin (Hgb) > 7 g/dL; Creatinine clearance (CrCl) ≥ 15 mL/min/1.73 m^2. Bilirubin (total) > 1.5x ULN; AST/ALT > 3x ULN [excluded]; exceptions for Gilbert's syndrome, ART, or lymphoma. ANC < 1000/mm^3 and platelets < 75,000/mm^3 unless related to lymphoma and/or KSHV-MCD or prior therapy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05907759 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anthracycline-containing chemotherapy.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages