What side effects are associated with this type of intervention?

Common treatments for Diffuse Large B-Cell Lymphoma (DLBCL) similar to the VIPOR-Nivo trial include combinations of lenalidomide, an immunomodulatory drug, and nivolumab, an immune checkpoint inhibitor. Lenalidomide is associated with side effects such as neutropenia, thrombocytopenia, anemia, fatigue, and an increased risk of serious infections. Nivolumab, on the other hand, can cause immune-related adverse events including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Both drugs require careful monitoring due to their potential for severe toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for Diffuse Large B-Cell Lymphoma (DLBCL) that involve immunomodulatory drugs and immune checkpoint inhibitors. Lenalidomide, an immunomodulatory drug, has been approved for use in combination with rituximab for relapsed or refractory DLBCL. Nivolumab, an immune checkpoint inhibitor, has been approved for various cancers but not specifically for DLBCL. However, other immune checkpoint inhibitors like pembrolizumab have shown efficacy in treating relapsed or refractory DLBCL. These approvals highlight the potential of combining immunomodulatory drugs and immune checkpoint inhibitors in treating DLBCL.

What other types of research exist?

Promising alternatives to VIPOR-Nivo for DLBCL patients include: 1) Polatuzumab vedotin combined with bendamustine and rituximab, which has shown efficacy in relapsed/refractory DLBCL. 2) CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have demonstrated significant responses in DLBCL. 3) Tafasitamab in combination with lenalidomide, which has been effective in relapsed/refractory DLBCL. 4) Bispecific antibodies like glofitamab, targeting CD20 and CD3, which are in advanced clinical trials and showing promising results.

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BTK Inhibitor

VIPOR Regimen for CNS-involved B-Cell Lymphoma

Phase 1

Waitlist Available

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

Must not have

History of any ventricular arrhythmia.

Inability to swallow capsules or significant gastrointestinal issues.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a combination of drugs called VIPOR-Nivo to treat adults with specific aggressive brain lymphomas that are hard to treat. The drugs work together to kill cancer cells and boost the immune system.

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.

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.

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

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I meet the age and health condition requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had irregular heartbeats from the lower chambers of my heart.

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I cannot swallow pills or have major stomach problems.

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I am currently taking warfarin or similar blood thinners.

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I have a bleeding disorder or hemophilia.

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I do not have plasmablastic lymphoma or B-cell lymphoma that is hard to classify.

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My heart condition is severe.

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I have a serious liver condition right now.

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I am currently receiving treatment for another cancer.

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I need ongoing treatment with a strong medication that affects liver enzymes.

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I do not have any ongoing or active infections that are not under control.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absence of toxicity/SAE

Secondary study objectives

Complete Response

Duration of Response

Overall Response Rate to VIPOR

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2240

Ibrutinib

2014

Completed Phase 4

~2060

Venetoclax

2019

Completed Phase 3

~2240

Obinutuzumab

2014

Completed Phase 3

~3470

Prednisone

2014

Completed Phase 4

~2500

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Diffuse Large B-Cell Lymphoma (DLBCL) is commonly treated with a combination of chemotherapy, immunotherapy, and targeted agents. Lenalidomide, an immunomodulatory drug, works by enhancing the immune system's ability to attack cancer cells, inhibiting angiogenesis, and directly killing lymphoma cells. Nivolumab, an immune checkpoint inhibitor, blocks the PD-1 pathway, which cancer cells use to evade immune detection, thereby allowing the immune system to recognize and destroy these cells. These mechanisms are crucial for DLBCL patients as they offer a multi-faceted approach to target and eliminate cancer cells, potentially leading to better treatment outcomes and prolonged survival.