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Bruton's Tyrosine Kinase (BTK) Inhibitor
Pirtobrutinib + Venetoclax for Mantle Cell Lymphoma
Phase 2
Recruiting
Led By Preetesh Jain, MD, DM, PhD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 1 year.
Awards & highlights
Study Summary
This trial is testing the combination of pirtobrutinib and venetoclax to see if it can help control mantle cell lymphoma that has come back or has not responded to other therapies.
Who is the study for?
Adults with relapsed or refractory Mantle Cell Lymphoma (MCL) who have measurable disease, an ECOG performance status of 2 or less, and adequate organ function. They must not be pregnant or breastfeeding, agree to use effective contraception, and cannot have central nervous system involvement by lymphoma, uncontrolled infections like HIV/HBV/HCV, significant heart issues, bleeding disorders, or other severe medical conditions.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining two drugs—Pirtobrutinib and Venetoclax—in treating MCL that has either returned after treatment or hasn't responded to previous therapies. The goal is to see if this drug combination can better control the disease.See study design
What are the potential side effects?
Potential side effects may include digestive disturbances such as nausea and diarrhea; blood-related issues like anemia; increased risk of infection due to immune suppression; liver enzyme alterations suggesting liver impact; fatigue; possible allergic reactions to medication components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR (overall response rate)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pirtobrutinib (LOXO-305) and Venetoclax (combination)Experimental Treatment2 Interventions
Participants will have study visits every week during Cycle 1, and then on Day 1 of every cycle for the first year. After that, they will have study visits on Day 1 of every 2 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,291 Total Patients Enrolled
Loxo OncologyUNKNOWN
Preetesh Jain, MD, DM, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma has affected my brain, but I am stable after treatment.I am 18 years or older.I can take pills by mouth.I have not had a stroke or brain bleed in the last 6 months.I can do most of my daily activities on my own.I haven't taken any experimental drugs within the last 2 weeks.I currently have an untreated or uncontrolled infection.I have at least one tumor that can be measured by scans.I have not received a live vaccine in the last 28 days.My MCL cancer has returned or didn't respond to treatment, regardless of previous therapies.I do not have any uncontrolled infections or other serious health conditions.I am using steroids for cancer pain but can stop before starting the study, or I take up to 20 mg of steroids daily for other conditions.My biopsy confirms I have mantle cell lymphoma, with or without specific genetic features.I have a history of unusual bleeding.I have relapsed Mantle Cell Lymphoma and may have had previous treatments but not venetoclax.I am not taking strong medications that affect liver enzymes or certain fruits.I am cancer-free except for minor skin cancers or cancers in remission not being treated, with a life expectancy over 3 years.My heart's electrical activity shows prolonged QT intervals on recent tests.My blood counts are within the required range without needing transfusions.I have no other cancers, or they are in remission for over a year, except for certain skin cancers or early-stage cervical cancer.I have a condition that affects my stomach or intestines' ability to absorb nutrients.I do not have active hepatitis B or C.I do not have serious heart problems like recent heart attacks or severe heart failure.My blood clotting tests are within normal range, or slightly above.I haven't had cancer treatments or major surgery recently.I have an uncontrolled immune-related blood condition that hasn't stabilized with recent treatment changes.I had severe bleeding or a serious irregular heartbeat from previous BTK inhibitor treatment.I have HIV but it's under control and I meet the health criteria specified.I have not had a stem cell or CAR-T therapy in the last 60 days and do not have ongoing complications from such treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Pirtobrutinib (LOXO-305) and Venetoclax (combination)
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.
When might Pirtobrutinib receive FDA approval?
"Pirtobrutinib's safety is estimated to be a 2 because, while there is data supporting its safety, there is no evidence that the drug actually works."
Answered by AI
Are there any current openings for volunteers in this clinical trial?
"This study, which was last updated on September 7th 2022 and originally posted on February 28th 2023 is not recruiting patients at this moment. Although, there are other 2,022 trials that are still looking for participants."
Answered by AI
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