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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 below
Select...
I meet the age and health condition requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years post-treatment for reporting.

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 more

Trial 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

Ibrutinib (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05211336 — Phase 1
Diffuse Large B-Cell Lymphoma Research Study Groups: 1: VIPOR
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT05211336 — Phase 1
Ibrutinib (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05211336 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~0 spots leftby Mar 2024