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NCT05211336 · ClinicalTrials.gov registry record · Phase 1
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System
A Phase 1 study of Primary Diffuse Large B-cell Lymphoma of the Central Nervous System (CNS) and Aggressive B-cell Lymphoma With Secondary Involvement of the CNS, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT05211336 is a Phase 1 study of Primary Diffuse Large B-cell Lymphoma of the Central Nervous System (CNS) and Aggressive B-cell Lymphoma With Secondary Involvement of the CNS that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05211336, a Phase 1 study of Primary Diffuse Large B-cell Lymphoma of the Central Nervous System (CNS) and Aggressive B-cell Lymphoma With Secondary Involvement of the CNS, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: People with primary diffuse large B-cell lymphoma of the central nervous system (CNS) and aggressive B-cell lymphomas with secondary CNS involvement have a poor prognosis. Researchers want to learn if a combination of drugs can help. Objective: To learn if it is safe to give people with these cancers Nivolumab (VIPOR-Nivo). Eligibility: People aged 18 and older with B-cell lymphoma in the CNS that does not respond to treatment, response to treatment does not last long, or there is no standard treatment. Design: Participants will be screened with: Health history Physical exam Blood, urine, and heart tests Computed tomography (CT), fludeoxyglucose F18 (FDG) positron emission tomography (PET), and magnetic resonance imaging (MRI) scans. Participants will lie in scanners that take pictures of the body. For some scans, a contrast or chemical agent will be injected into a vein. Lumbar puncture or Ommaya tap. Participants will have a small needle inserted into their lower back or scalp to obtain fluid. Possible tumor biopsy. Participants will have a needle inserted into a tumor to take a sample. Participants will get the study drugs in 21-day cycles. They may have up to 6 treatment cycles. They will take some drugs by infusion into a vein and some drugs by mouth. Participants will get counseling at least every 28 days on the risks of lenalidomide. Participants will have visits throughout the study. Visits may include repeats of the screening tests. They may also include: Bone marrow biopsy. Participants will have a needle inserted into their hipbone to remove marrow. Saliva samples and cheek swabs Participants will have periodic follow-up visits for about 10 years.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Lenalidomide
- DRUG Prednisone
- DRUG Ibrutinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-04-19 |
| Est. Completion | 2029-06-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05211336
The ClinicalTrials.gov registry entry for NCT05211336 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 14 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 2 conditions, with Primary Diffuse Large B-cell Lymphoma of the Central Nervous System (CNS) appearing as the primary indexed condition, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT05211336 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05211336 about?
NCT05211336 is a clinical study titled "Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System". Background: People with primary diffuse large B-cell lymphoma of the central nervous system (CNS) and aggressive B-cell lymphomas with secondary CNS involvement have a poor prognosis. Researchers want to learn if a combination of drugs can help. Objective: To learn if it is safe to give people wi...
What is the current status of trial NCT05211336?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-04-19. Estimated completion is 2029-06-01.
What conditions does trial NCT05211336 study?
This clinical trial studies the following conditions: Primary Diffuse Large B-cell Lymphoma of the Central Nervous System (CNS), Aggressive B-cell Lymphoma With Secondary Involvement of the CNS.
What interventions are being tested in trial NCT05211336?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Lenalidomide (DRUG), Prednisone (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT05211336?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05211336 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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