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NCT05907759 · ClinicalTrials.gov registry record · Phase 2
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
A Phase 2 study of Lymphoma, Primary Effusion, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05907759 is a Phase 2 study of Lymphoma, Primary Effusion that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05907759, a Phase 2 study of Lymphoma, Primary Effusion, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Daratumumab SC
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-07-10 |
| Est. Completion | 2035-12-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05907759
The ClinicalTrials.gov registry entry for NCT05907759 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lymphoma, Primary Effusion appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab SC is the first listed.
NCT05907759 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05907759 about?
NCT05907759 is a clinical study titled "Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease". 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 tre...
What is the current status of trial NCT05907759?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2024-07-10. Estimated completion is 2035-12-01.
What conditions does trial NCT05907759 study?
This clinical trial studies the following conditions: Lymphoma, Primary Effusion.
What interventions are being tested in trial NCT05907759?
The interventions under investigation include: Daratumumab SC (DRUG).
Who is sponsoring clinical trial NCT05907759?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05907759 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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