OncoMatch/Clinical Trials/NCT05907759
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
Is NCT05907759 recruiting? Yes, currently enrolling (May 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
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline-containing chemotherapy — frontline
has relapsed, and/or is refractory after frontline chemotherapy, or who are ineligible for front-line chemotherapy
Cannot have received: anticancer treatment
Exception: local treatment for carcinoma in situ or hormonal therapy for prostate or breast carcinoma
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.
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; or if elevated due to ART or lymphoma); AST/ALT <= 3x ULN (unless due to ART or lymphoma)
Cardiac function
No clinically significant cardiac disease, including: myocardial infarction within 6 months, unstable angina, congestive heart failure (NYHA Class III-IV), uncontrolled cardiac arrhythmia
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 excluded; AST/ALT > 3x ULN excluded; exceptions for Gilbert's syndrome or if 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 clinically significant cardiac disease, including: myocardial infarction within 6 months, unstable angina, congestive heart failure (NYHA Class III-IV), uncontrolled cardiac arrhythmia.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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