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B-cell Lymphoma-2 (BCL-2) Inhibitor
Pirtobrutinib + Venetoclax for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Philip Thompson, MD
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
Absolute neutrophil count (ANC) >= 1000/ul in the absence of growth factor support
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to completion of cycle 24 (each cycle is 28 days)
Awards & highlights
Study Summary
This trial is testing if a combination of two drugs can help control CLL/SLL that has been previously treated.
Who is the study for?
Adults with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have completed at least 12 cycles of venetoclax and still have detectable minimal residual disease. Participants must be in generally good health, with adequate organ function and blood counts, not pregnant or breastfeeding, willing to use effective contraception, and without certain heart conditions or other serious medical issues.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining a new drug called pirtobrutinib (LOXO-305) with an existing treatment, venetoclax, to see if this combination can better control CLL/SLL after previous treatments. The goal is to eliminate any remaining cancer cells that were not cleared by prior therapy.See study design
What are the potential side effects?
Potential side effects may include diarrhea, fatigue, muscle and bone pain from pirtobrutinib; nausea, low white blood cell count leading to increased infection risk from venetoclax. There could also be risks associated with taking both medications together which are currently unknown.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is healthy without needing medication.
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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.
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My kidneys are functioning well enough (creatinine clearance >= 30 ml/min).
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I've been treated with venetoclax for 12 cycles and still have minimal cancer cells detected.
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I have been diagnosed with CLL according to the 2018 IWCLL criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to completion of cycle 24 (each cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to completion of cycle 24 (each cycle is 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of undetectable (U) minimal residual disease (MRD) in the peripheral blood
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pirtobrutinib+venetoclaxExperimental Treatment2 Interventions
Pirtobrutinib by mouth at the same time each day Venetoclax by mouth at the same time each day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,317 Total Patients Enrolled
253 Trials studying Lymphoma
32,498 Patients Enrolled for Lymphoma
Philip Thompson, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Alessandra Ferrajoli, MDPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
403 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a stem cell transplant or CAR-T therapy in the last 60 days and don't have active GVHD, need for anti-cytokine therapy, symptoms of neurotoxicity > grade 1, or uncontrolled auto-immune cytopenia.I had a major bleeding event while on a BTK inhibitor.I have been treated with a BTK inhibitor like nemtabrutinib before.I haven't taken cancer drugs (except for breast/prostate cancer hormones or venetoclax) recently.My CLL is affecting or might affect my brain or spinal cord.My condition has transformed into a more aggressive form of cancer.I need blood thinners like warfarin for my condition.I have not had major surgery in the last 4 weeks.My platelet count is at least 50,000 without recent transfusions.My white blood cell count is healthy without needing medication.I can take care of myself but might not be able to do heavy physical work.I am not taking more than 20 mg of prednisone or any similar steroid daily for cancer treatment.I do not have any uncontrolled infections or other serious health issues.I have a condition that affects how my body absorbs medication taken by mouth.I am 18 years old or older.I don't have any lasting side effects from previous treatments, except for hair loss.I have not received a live vaccine in the last 28 days.I have had a severe irregular heartbeat from previous BTK inhibitor treatment.I have a second cancer but it's unlikely to need treatment in the next 2 years.I am not allergic to any part of LOXO-305 or venetoclax.My kidneys are functioning well enough (creatinine clearance >= 30 ml/min).I've been treated with venetoclax for 12 cycles and still have minimal cancer cells detected.I do not have active hepatitis B or C.I do not have serious heart problems.I have been diagnosed with CLL according to the 2018 IWCLL criteria.I am not taking any strong medications that affect liver enzymes or consuming grapefruit, Seville oranges, or star fruit.I am not pregnant, will use effective birth control during and after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Pirtobrutinib+venetoclax
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Is this research project still open to new participants?
"From what is detailed on clinicaltrials.gov, this particular trial has closed recruitment. The study was first announced on September 30th, 2022 and underwent its last edit on April 7th, 2022. Even though this opportunity to participate has passed, there are 2,954 other trials that are still recruiting patients."
Answered by AI
Is it possible to experience negative side effects from Pirtobrutinib?
"Pirtobrutinib falls into the category of a phase 2 drug, meaning that while there is some data supporting its safety, there is no evidence yet to suggest that it is effective. Therefore, our team at Power gave it a score of 2."
Answered by AI
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