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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)
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
Study Summary
This trial is studying the safety of ViPOR for people with B-cell lymphoma.
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.Check my eligibility
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.See study design
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.
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
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
Overall response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
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
~2370
Ibrutinib
2014
Completed Phase 3
~1880
Obinutuzumab
2015
Completed Phase 3
~3250
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,925,988 Total Patients Enrolled
Christopher J Melani, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
356 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the patient population being monitored in this clinical experiment?
"Affirmative. Clinicaltrials.gov data verify that this research endeavour was first posted on February 9th 2018 and recently revised on October 4th 2022, seeking to enrol 130 participants from 1 site."
Answered by AI
What ailments can be addressed with the administration of Venetoclax?
"Venetoclax is frequently prescribed to patients who have been exposed to two or more systemic chemotherapy treatments. It also has the potential of being effective against thyroiditis, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."
Answered by AI
Is this investigation taking on new participants?
"As verified on clinicaltrials.gov, this medical trial is presently enlisting patients. It was initially published on February 9th 2018 and the most recent update occurred October 4th 2022."
Answered by AI
Are there any past or current investigations involving Venetoclax?
"Venetoclax is currently the subject of 945 active studies with 191 in Phase 3. Most are centred around Edmonton, Alberta; yet, there exist 40084 trials sites worldwide studying this medication."
Answered by AI
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