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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: Active 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).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of participants who complete at least 2 cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) therapy without stopping due to toxicity will be determined and reported along with a 95% confidence interval. Success is defined as completing at least 2 cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) therapy without the need to discontinue treatment due to toxicity (i.e., serious adverse event). A serious adverse event is an adv
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 |
What the registry record for NCT05211336 still lists
NCT05211336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05211336's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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