← Back to Search

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).
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

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years or older.
Select...
My lymphoma is an aggressive type, such as DLBCL or Burkitt.
Select...
My B-cell lymphoma didn't respond or came back after treatment with an anti-CD20 drug.
Select...
My aggressive B-cell lymphoma didn't respond to or came back after treatment with an anthracycline.
Select...
My condition worsened or didn't improve after at least one treatment.
Select...
My condition is not CLL/SLL due to specific treatment and risk concerns.
Select...
I do not have active CNS lymphoma.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years old or older.
Select...
My cancer is not mantle cell lymphoma due to the risk of TLS with venetoclax treatment.
Select...
I am 18 years old or older.
Select...
My lymphoma is confirmed to be of B-cell type.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and grade of adverse events
Secondary outcome measures
Complete response (CR) rate
Duration of Response (DOR)
Event-free survival (EFS)
+3 more

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
2021
Completed Phase 2
~750
obinutuzumab
2018
Completed Phase 3
~2630
Revlimid
2005
Completed Phase 3
~730
ibrutinib
2012
Completed Phase 3
~1390
prednisone
1999
Completed Phase 3
~10920

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,850 Total Patients Enrolled
Christopher J Melani, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
446 Total Patients Enrolled

Media Library

Ibrutinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04739813 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Arm 1: Dose Escalation, Arm 2: Dose Expansion
Non-Hodgkin's Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT04739813 — Phase 1
Ibrutinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04739813 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree does Polatuzumab pose a risk to human life?

"Limited evidence of both safety and efficacy means that Polatuzumab's rating on the scale is 1."

Answered by AI

What therapeutic applications is Polatuzumab typically utilized for?

"Polatuzumab is an effective treatment option for two types of prior chemotherapy regimens, as well as thyroiditis, ulcerative colitis, and acute retinal necrosis caused by the varicella-zoster virus."

Answered by AI

Is there a recruitment drive presently underway for this research?

"Clinicaltrials.gov confirms that this investigation, which was initially posted on July 9th 2021, is presently searching for participants. The trial has most recently been updated on October 20th 2022."

Answered by AI

How many volunteers are engaged in this experiment?

"Affirmative. As per clinicaltrials.gov, the trial which first opened for recruitment on July 9th of 2021 is currently accepting applicants with 32 subjects needed from one centre."

Answered by AI

Have any previous tests been conducted with Polatuzumab?

"Currently, there are 191 Phase 3 trials and 945 overall studies that involve Polatuzumab. The majority of these clinical tests are situated in Edmonton, Alberta; however, the medication is being tested across 40 088 other sites worldwide."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
2021. "Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04739813.
~3 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top