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Kinase Inhibitor

ViPOR-P for B-Cell Lymphoma

Phase 1

Recruiting

Led By Christopher J Melani, 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

NOTE: Because no dosing or adverse event data are currently available on the use of polatuzumab in combination with venetoclax, ibrutinib, obinutuzumab, prednisone and Revlimid in patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.

Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as high-grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangement(s).

Must not have

Uncontrolled intercurrent illness

Malabsorption syndrome or other condition that precludes enteral route of administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the date of study enrollment until death from any cause, assessed every 3-6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to see if it is safe and effective to give to people with certain B-cell lymphomas.

Who is the study for?

Adults over 18 with B-cell lymphoma that has come back or didn't respond to treatment can join. They must have tried at least one cancer therapy, be in good health otherwise, and agree to use birth control. People with certain types of lymphoma like MCL or active CNS involvement, pregnant women, those with liver disease or HIV, and anyone on conflicting medications are excluded.

What is being tested?

The trial tests a drug combo (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Revlimid & Polatuzumab) for B-cell lymphomas resistant to standard treatments. Participants will take some drugs orally and receive others through IV for up to six cycles lasting 21 days each.

What are the potential side effects?

Possible side effects include reactions where the IV is given; changes in blood counts leading to increased infection risk; fatigue; digestive issues; potential liver problems; and allergic reactions. Specific side effects depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older.

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My lymphoma is an aggressive type, such as DLBCL or Burkitt.

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My B-cell lymphoma didn't respond or came back after treatment with an anti-CD20 drug.

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My aggressive B-cell lymphoma didn't respond to or came back after treatment with an anthracycline.

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My condition worsened or didn't improve after at least one treatment.

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My condition is not CLL/SLL due to specific treatment and risk concerns.

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I do not have active CNS lymphoma.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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My cancer is not mantle cell lymphoma due to the risk of TLS with venetoclax treatment.

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I am 18 years old or older.

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My lymphoma is confirmed to be of B-cell type.

Exclusion Criteria

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

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I do not have any unmanaged ongoing illnesses.

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I cannot take medicine by mouth due to a digestive condition.

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I had an organ or stem cell transplant less than 6 months ago or have ongoing graft-versus-host disease.

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I am taking warfarin.

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I have a significant history of liver problems.

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I am HIV-positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the date of study enrollment until death from any cause, assessed every 3-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the date of study enrollment until death from any cause, assessed every 3-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the date of study enrollment until death from any cause, assessed every 3-6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number and grade of adverse events

Secondary study objectives

Complete response (CR) rate

Duration of Response (DOR)

Event-free survival (EFS)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: Dose ExpansionExperimental Treatment6 Interventions

Venetoclax (PO) at the MTD days 2-14, ibrutinib (PO) 560mg on days 1-14, prednisone (PO) 100mg on days 1-7, obinutuzumab 1000mg (IV) on days 1 and 2, lenalidomide (PO) 15mg on days 1-14, and polatuzumab (IV) at the MTD of each 21-day cycle (maximum 6 cycles)

Group II: Arm 1: Dose EscalationExperimental Treatment6 Interventions

Venetoclax (PO) 800mg at escalating doses (2 dose levels) on days 2-14, ibrutinib (PO) 560mg on days 1-14, prednisone (PO) 100mg on days 1-7, obinutuzumab 1000mg (IV) on days 1 and 2, lenalidomide (PO) 15mg on days 1-14, and polatuzumab (IV) at escalating doses (2 dose levels) on day 2 of each 21-day cycle (maximum 6 cycles) to determine MTD of polatuzumab and venetoclax

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

venetoclax

2014

Completed Phase 2

~740

obinutuzumab

2018

Completed Phase 3

~2630