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Immunomodulatory Agent
Venetoclax + Lenalidomide + Rituximab for Mantle Cell Lymphoma
Phase 1
Waitlist Available
Led By Ryan Wilcox, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL
ECOG Performance Status less or equal to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial will test if an experimental drug called venetoclax, when combined with lenalidomide and rituximab, is safe and effective in treating people with Mantle Cell Lymphoma.
Who is the study for?
This trial is for adults over 18 with untreated Mantle Cell Lymphoma, who are in relatively good health (ECOG ≤2), not pregnant or breastfeeding, and can take oral medication. They must join the Revlimid REMS® program, agree to pregnancy testing if applicable, use contraception, and have no recent strong drug interactions or other cancers within 2 years.Check my eligibility
What is being tested?
The study tests a combination of venetoclax with lenalidomide and rituximab for safety and effectiveness against MCL. Participants will receive this experimental treatment to see how well it works compared to current treatments.See study design
What are the potential side effects?
Possible side effects include digestive issues, risk of infection due to lowered immune response, potential allergic reactions to drugs involved, fatigue from treatment regimen impact on body's normal function. Specific side effect profiles will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tests show I have mantle cell lymphoma.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
Select...
My diagnosis is mantle cell lymphoma confirmed by tissue examination.
Select...
I am registered and can follow the Revlimid REMS program requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab
Secondary outcome measures
The proportion of patients that respond to treatment
The proportion of patients with a Complete Response (CR)
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Hypokalaemia
11%
Blood creatinine increased
11%
Neutrophil count decreased
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Dermatitis
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
1Treatment groups
Experimental Treatment
Group I: Venetoclax, Lenalidomide, RituximabExperimental Treatment3 Interventions
Rituximab 375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12 Lenalidomide 10 mg day 1-7 of and 15 mg day 8-14 cycle #1. 20 mg PO day day 15-21 of cycle #1 and days 1-21 cycles 2-12. Venetoclax PO days 8 - 28 cycles during cycle 1 only. Starting with ramp-up dose as follows (50 mg x 7 days then 100mg x 7 days then 200 mg x 7 days then 400 mg for remainder of therapy). Will be given days 1-28 at a dose of 400 mg cycle 2-12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Lenalidomide
2005
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,234 Total Patients Enrolled
Ryan Wilcox, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
2 Previous Clinical Trials
6 Total Patients Enrolled
Tycel Phillips, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to follow the pregnancy testing schedule as required.My cancer has spread to my brain or spinal cord.I have had cancer before, but it was either skin cancer treated successfully, cervical cancer that did not spread, or any cancer I've been free from for 2+ years.I have received chemotherapy for mantle cell lymphoma.I have taken a strong or moderate drug that affects liver enzymes within the last week.My tests show I have mantle cell lymphoma.I have not had a stroke or brain bleed in the last 6 months.I can swallow pills.I can take care of myself but might not be able to do heavy physical work.I have a serious heart condition.I am 18 years old or older.I do not have an active Hepatitis B or C infection.I do not have any conditions that could affect how my body absorbs medication.You have a mental health condition or personal circumstances that may make it difficult for you to follow the study rules.I do not have any untreated infections and haven't had IV antibiotics in the last 2 weeks.I have moderate to severe numbness, tingling, or pain in my hands or feet.I am using effective birth control methods.My organs are working well.My diagnosis is mantle cell lymphoma confirmed by tissue examination.I am registered and can follow the Revlimid REMS program requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax, Lenalidomide, Rituximab
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.
To what extent has recruitment for this project been completed?
"This trial has concluded its patient recruitment process. Initially posted on December 24th 2018, the study was last updated October 18th 2022. There are currently 1720 trials for lymphoma actively recruiting patients and 798 separate studies enrolling participants to use Venetoclax as a treatment option."
Answered by AI
For what purposes is Venetoclax typically utilized?
"Venetoclax is widely prescribed to diffuse large b-cell lymphoma patients, as well as those with at least two prior systemic therapies and other forms of B cell lymphomas. It can also be used for the management of polyangium."
Answered by AI
Are there any remaining vacancies in this medical experiment?
"Unfortunately, patient recruitment for this study has concluded. It was initially posted on December 24th 2018 and the last update occurred October 18th 2022. If you are searching for other trials, there are currently 1720 clinical studies with lymphoma as its focus that actively accept patients and 798 relating to Venetoclax which seek participants."
Answered by AI
What additional research has been undertaken in relation to Venetoclax?
"Venetoclax was first trialled in 1993 at the NIH Clinical Center, 9000 Rockville Pike. Since then, 1145 studies have been fully completed and 798 new trials are being actively recruited for. The bulk of these studies are taking place in Columbus, Ohio."
Answered by AI
Has the FDA sanctioned Venetoclax for therapeutic use?
"The risk-benefit profile of Venetoclax has been deemed relatively low at this point, being assigned a rating of 1 on our scale due to the limited data available from Phase 1 trials."
Answered by AI
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