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BTK Inhibitor
VIPOR Regimen for CNS-involved B-Cell Lymphoma
Phase 1
Recruiting
Led By Mark J Roschewski, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must meet specific age and performance status criteria.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years post-treatment
Awards & highlights
Study Summary
This trialstudies whether a drug combo can help people with B-cell CNS lymphoma live longer. Participants will be screened and may have scans, biopsies, and bone marrow tests. They will get drugs and counseling. Visits and follow-up may take 10 yrs.
Who is the study for?
Adults aged 18+ with B-cell lymphoma in the CNS that's unresponsive to treatment, relapsed after treatment, or ineligible for standard therapy due to age or kidney function. Must have measurable disease and adequate organ/marrow function. Participants must not be pregnant, agree to use birth control, and can't have certain other cancers needing active treatment.Check my eligibility
What is being tested?
The VIPOR-Nivo trial is testing a combination of drugs (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Revlimid) on patients with primary diffuse large B-cell lymphoma of the CNS or aggressive B-cell lymphomas with secondary CNS involvement. The study involves up to six 21-day cycles of medication taken orally and by infusion.See study design
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in various organs; blood disorders; increased risk of infections; fatigue; digestive issues like nausea or constipation; allergic reactions from infusions; and liver problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I meet the age and health condition requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absence of toxicity/SAE
Secondary outcome measures
Complete Response
Duration of Response
Overall Response Rate to VIPOR
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 1: VIPORExperimental Treatment5 Interventions
VIPOR (venetoclax, ibrutinib, prednisone, obinutuzumab, lenalidomide) in 21-day cycles for up to 6 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Ibrutinib
2014
Completed Phase 3
~1880
Venetoclax
2019
Completed Phase 3
~1990
Obinutuzumab
2015
Completed Phase 3
~3250
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,335 Total Patients Enrolled
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had irregular heartbeats from the lower chambers of my heart.I cannot swallow pills or have major stomach problems.I haven't had chemotherapy, radiation, or antibody treatment in the last 7 days.I have a second cancer that doesn't need ongoing treatment.My organs and bone marrow are working well.I am currently taking warfarin or similar blood thinners.I have a bleeding disorder or hemophilia.My lymphoma is a specific type that affects the brain or has spread there.I do not have plasmablastic lymphoma or B-cell lymphoma that is hard to classify.My heart condition is severe.I have a serious liver condition right now.I am currently receiving treatment for another cancer.I have been treated with specific medication classes before.I need ongoing treatment with a strong medication that affects liver enzymes.My disease came back or didn't respond after the first treatment, or I can't have standard treatment due to my health.I have hepatitis B or C but my viral load is undetectable.I do not have any ongoing or active infections that are not under control.I meet the age and health condition requirements.
Research Study Groups:
This trial has the following groups:- Group 1: 1: VIPOR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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