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BTK Inhibitor
ViPOR for Lymphoma
Phase 1 & 2
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
Patients must have histologically or cytologically confirmed B-cell lymphoma confirmed by the Laboratory of Pathology, NCI
Patients with aggressive B-cell lymphoma must have 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
History of other active malignancy that could affect compliance with the protocol or interpretation of results
Patients with recent chemotherapy, external beam radiation therapy, or anti-cancer antibodies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the date of from initial diagnosis until death from any cause; assessed every 3-6 months
Awards & highlights
Summary
This trial tests a combination of five drugs (ViPOR) to treat adults with B-cell lymphoma that has come back or not responded to other treatments. The drugs work together to block cancer cell survival mechanisms. One of the drugs, Venetoclax, is already used for another type of blood cancer and is being studied for its effectiveness in this treatment. The study aims to find the safest dose and see how well the treatment works.
Who is the study for?
Adults over 18 with B-cell lymphoma that has come back or hasn't improved after treatment can join. They must have had at least one prior regimen including an anti-CD20 antibody and be in good enough health to participate. Women who can bear children and men must agree to use contraception, and all participants need counseling on lenalidomide risks regularly.
What is being tested?
The ViPOR combination (venetoclax, ibrutinib, prednisone, obinutuzumab, lenalidomide) is being tested for safety in treating B-cell lymphomas. Participants will receive these drugs in cycles of 21 days up to six times, with close monitoring especially after the first dose of venetoclax.
What are the potential side effects?
Possible side effects include reactions from IV drug administration, digestive issues due to oral medications, blood disorders from bone marrow impact, increased risk of infections due to immune system suppression by the drugs used in this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is confirmed to be of B-cell type by a pathology lab.
Select...
My lymphoma is an aggressive type, such as DLBCL, Burkitt, or high-grade with specific gene rearrangements.
Select...
I do not have active CNS lymphoma.
Select...
I can take care of myself and perform daily activities.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have another active cancer that could interfere with the study.
Select...
I have recently undergone chemotherapy, radiation, or received cancer-fighting antibodies.
Select...
I have a significant history of liver problems, including hepatitis, alcohol abuse, or cirrhosis.
Select...
I cannot take medicine by mouth due to a digestive condition.
Select...
I have not had major surgery in the last 6 weeks.
Select...
I have been treated with more than one of the drugs being studied before.
Select...
I had a stem cell transplant less than 6 months ago or I have signs of graft-versus-host disease.
Select...
I need to take warfarin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from the date of from initial diagnosis until death from any cause; assessed every 3-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the date of from initial diagnosis until death from any cause; assessed every 3-6 months
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
Overall response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
4Treatment groups
Experimental Treatment
Group I: Arm 4: Dose ExpansionExperimental Treatment5 Interventions
iPOR (ibrutinib, prednisone, obinutuzumab, lenalidomide) for cycle 1; followed by ViPOR (venetoclax, ibrutinib, prednisone, obinutuzumab, lenalidomide) for cycles 2-6
Group II: Arm 3: Dose ExpansionExperimental Treatment5 Interventions
ViPOR (venetoclax, ibrutinib, prednisone, obinutuzumab, lenalidomide) for cycles 1-6
Group III: Arm 2: Dose EscalationExperimental Treatment5 Interventions
ViPOR (venetoclax, ibrutinib, prednisone, obinutuzumab, lenalidomide) for cycles 1-6
Group IV: Arm 1: Dose EscalationExperimental Treatment5 Interventions
iPOR (ibrutinib, prednisone, obinutuzumab, lenalidomide) for cycle 1; followed by ViPOR (venetoclax, ibrutinib, prednisone, obinutuzumab, lenalidomide) for cycles 2-6
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Revlimid (lenalidomide)
2007
Completed Phase 2
~160
Prednisone
2014
Completed Phase 4
~2500
Ibrutinib
2014
Completed Phase 4
~2060
Obinutuzumab
2014
Completed Phase 3
~3470
Venetoclax
2019
Completed Phase 3
~2200
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
The most common treatments for Non-Hodgkin's Lymphoma (NHL) include venetoclax, which inhibits the BCL-2 protein to promote cancer cell apoptosis; ibrutinib, which inhibits Bruton's tyrosine kinase (BTK) to disrupt B-cell receptor signaling and reduce cancer cell survival; prednisone, a corticosteroid that reduces inflammation and suppresses the immune response; obinutuzumab, a monoclonal antibody targeting CD20 on B-cells to induce cell death; and lenalidomide, which modulates the immune system and has anti-angiogenic properties to inhibit tumor growth. These mechanisms are vital for NHL patients as they offer targeted approaches to eliminate cancer cells, improve treatment efficacy, and manage disease progression.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,872 Previous Clinical Trials
41,010,632 Total Patients Enrolled
Christopher J Melani, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
344 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong CYP3A inhibitors or inducers in the last week.I do not have any severe illnesses that could affect the study results or increase my risk.I do not have another active cancer that could interfere with the study.My lymphoma is confirmed to be of B-cell type by a pathology lab.I have recently undergone chemotherapy, radiation, or received cancer-fighting antibodies.I have a significant history of liver problems, including hepatitis, alcohol abuse, or cirrhosis.I cannot take medicine by mouth due to a digestive condition.I have not had major surgery in the last 6 weeks.My lymphoma is an aggressive type, such as DLBCL, Burkitt, or high-grade with specific gene rearrangements.I do not have active CNS lymphoma.I can take care of myself and perform daily activities.I have been treated with more than one of the drugs being studied before.I need to take warfarin.I have indolent B-cell lymphoma but not CLL/SLL.I had a stem cell transplant less than 6 months ago or I have signs of graft-versus-host disease.I have fully recovered from any side effects of past cancer treatments or surgeries.My disease can be measured or observed through tests or imaging.I am 18 years old or older.I agree to use birth control during the study.My organs and bone marrow are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Dose Escalation
- Group 2: Arm 3: Dose Expansion
- Group 3: Arm 4: Dose Expansion
- Group 4: Arm 2: Dose Escalation
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.
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