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BTK Inhibitor
Ibrutinib + Venetoclax for Mantle Cell Lymphoma
Phase 3
Waitlist Available
Research Sponsored by Pharmacyclics LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
At least 1, but no more than 5, prior treatment regimens for MCL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment vs. the standard treatment to see if the new treatment is more effective and has fewer side effects.
Who is the study for?
This trial is for adults with Mantle Cell Lymphoma who've had 1-5 prior treatments but haven't responded well. They must have a confirmed diagnosis, measurable disease on scans, and good organ function. Excluded are those with allergies to study drugs, recent heart attacks or strokes, active infections like HIV/HCV/HBV, severe liver issues, or gastrointestinal problems that affect drug absorption.Check my eligibility
What is being tested?
The SYMPATICO study tests the effectiveness of combining Ibrutinib (a known cancer drug) with Venetoclax versus Ibrutinib with a placebo in treating Mantle Cell Lymphoma. Participants will be randomly assigned to one of these two groups without knowing which one they're in.See study design
What are the potential side effects?
Possible side effects include diarrhea, nausea, low blood cell counts leading to increased infection risk or bleeding problems; fatigue; muscle and bone pain; and potential liver dysfunction. Some may experience serious complications such as infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as MCL with specific markers or genetic evidence.
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I have had between 1 and 5 treatments for mantle cell lymphoma.
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My last cancer treatment did not work or my cancer got worse after it.
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I have a recent or preserved tissue sample available.
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I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR) (Treatment-Naive Arm)
Duration of Response (DOR) (Safety Run-in Period)
Number of Participants With Adverse Events (AEs) (Safety Run-in Period)
+6 moreSecondary outcome measures
AUC of Venetoclax (Randomization Period)
AUClast if Ibrutinib (Randomization Period)
Cmax if Ibrutinib (Randomization Period)
+15 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment-naiveExperimental Treatment2 Interventions
This open-label arm is designed to explore the efficacy and safety of the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL.
Approximately 75 subjects (of which ~25 subjects with TP53 mutation) will be enrolled and treated with ibrutinib and venetoclax.
Group II: Safety Run-in PeriodExperimental Treatment2 Interventions
Subjects are enrolled into the open-label Safety Run-in Period to evaluate the occurrence of tumor lysis syndrome (TLS) and DLTs with the concurrent administration of ibrutinib and venetoclax.
Safety run-in phase for the study is closed to further enrollment as of 07-Nov-2018.
Group III: Phase 3: Ibrutinb + VenetoclaxExperimental Treatment2 Interventions
Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity
Group IV: Phase 3: Ibrutinib + PlaceboPlacebo Group2 Interventions
Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Ibrutinib
2014
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
Pharmacyclics LLC.Lead Sponsor
113 Previous Clinical Trials
13,468 Total Patients Enrolled
Janssen Research & Development, LLCIndustry Sponsor
975 Previous Clinical Trials
6,383,956 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer treatment in the last 21 days.I have a history of HIV or active hepatitis B or C.My cancer is confirmed as MCL with specific markers or genetic evidence.I have had between 1 and 5 treatments for mantle cell lymphoma.My last cancer treatment did not work or my cancer got worse after it.I have a recent or preserved tissue sample available.I am able to get out of my bed or chair and move around.I have or had lymphoma in my brain or spinal cord.I have not had major surgery in the last 4 weeks.I cannot take pills due to issues with my digestive system.I have not taken strong or moderate CYP3A inhibitors or inducers in the last week.I am allergic to certain medications used for treating high levels of uric acid in the blood.I am not in another treatment study and have not taken ibrutinib or similar drugs.I haven't taken strong medication that affects liver enzymes in the last week.I am not in another drug study and haven't taken ibrutinib or similar drugs.I do not have any ongoing infections that aren’t being treated.My condition is a specific type of mantle cell lymphoma.I have not had a stroke or brain bleed in the last 6 months.I have a known bleeding disorder like von Willebrand's or hemophilia.I am willing and able to follow all study requirements.If you have a serious health condition that could put you at risk during the study.I finished IV treatment for a serious infection less than 14 days ago.I have been treated with venetoclax or similar medications before.I am 18 or older and have a TP53 mutation.I have not had a heart attack or unstable heart conditions in the last 6 months.I have not received any live vaccines in the last 4 weeks.You have experienced an allergic reaction to any part of the study drug.My blood, liver, and kidney functions are all within normal ranges.My liver disease is moderate to severe.
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 are some of the most frequent reasons why patients are prescribed Venetoclax?
"Venetoclax has shown to be an effective treatment for waldenstrom macroglobulinemia, small lymphocytic lymphoma, and chronic lymphocytic leukemia (cll)."
Answered by AI
What is the status of Venetoclax's FDA approval process?
"Venetoclax receives a safety score of 3 from Power. This is due to the fact that Venetoclax is in Phase 3 trials, meaning that there is both some efficacy data as well as multiple rounds of data supporting safety."
Answered by AI
Are there other research facilities in the state conducting this investigation?
"20 sites are currently participating in this study, which includes locations such as New york, Houston, and Tucson. To reduce participant burden, it is advisable to select the location nearest you."
Answered by AI
Do you have any information on prior research using Venetoclax?
"As of right now, there are 355 clinical trials studying Venetoclax with 46 of those being in Phase 3. The many trials for Venetoclax are primarily based in Edmonton, Alberta, but there are 11787 total locations running trials for this treatment."
Answered by AI
How many patients are being monitored for this research project?
"Unfortunately, this study is not presently enrolling patients. Although, it's important to note that the trial was first posted on 6/29/2017 and was last edited on 9/8/2022. Additionally, there are presently 1756 clinical trials actively looking for participants with mantle cell lymphoma (mcl) and 355 studies for Venetoclax actively recruiting patients."
Answered by AI
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