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Bruton Tyrosine Kinase (BTK) inhibitor
Pirtobrutinib + Venetoclax for Waldenström Macroglobulinemia
Phase 2
Recruiting
Led By Jorge Castillo, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤2
Men must agree to use a latex condom during sexual contact with a female of childbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing if a combination of pirtobrutinib and venetoclax can treat Waldenström Macroglobulinemia.
Who is the study for?
This trial is for adults over 18 with Waldenström Macroglobulinemia who've had at least one prior treatment. They must have symptoms needing treatment, measurable disease (IgM paraprotein), and normal organ/marrow function. Women of childbearing age and men must use contraception. Exclusions include major recent surgery, other clinical trials, certain heart conditions or infections, inability to swallow pills, drug abuse history, and known allergies to the drugs' components.Check my eligibility
What is being tested?
The study tests the combination of pirtobrutinib (a BTK inhibitor) and venetoclax (a BCL2 inhibitor) for safety and effectiveness in treating Waldenström Macroglobulinemia. It aims to see if this drug duo can help patients who have already tried other treatments without success.See study design
What are the potential side effects?
Potential side effects may include bleeding events or heart rhythm issues due to pirtobrutinib; also common are gastrointestinal symptoms like nausea or diarrhea from venetoclax. Other possible reactions could be fatigue, infection risk increase due to immune system suppression by both drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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I agree to use a condom during sex if my partner can have children.
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My organs and bone marrow are functioning normally.
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My blood test shows high levels of IgM, more than twice the normal limit.
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I have been diagnosed with Waldenström Macroglobulinemia without MYD88 mutation.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Very Good Partial Response (VGPR) or Better Response Rate
Secondary outcome measures
Best Response
Grade 3-5 Treatment-related Toxicity Rate
Median Duration of Response (DOR)
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PIRTOBRUTINIB + VENETOCLAXExperimental Treatment2 Interventions
Participants will receive:
Standard of care bone marrow aspirate & biopsy within 90 days of Cycle 1 Day 1.
Computed Tomography (CT) scan of chest, pelvis & abdomen within 90 days of Cycle 1 Day 1.
Electrocardiogram at screening.
Cycle 1
Electrocardiogram.
Day 1-28: Predetermined dose of Pirtobrutinib 1x daily.
Cycle 2
-Day 1-28: Predetermined dose Pirtobrutinib & Venetoclax 1x daily. Tumor lysis syndrome (TLS) prophylaxis, predetermined dose Allopurinol at least 72 hrs prior to 1st administration of Venetoclax and dose escalation at Day 8 & Day 15.
Cycles 3-24
Day 1-28: Predetermined dose of Pirtobrutinib & Venetoclax 1x daily.
Electrocardiogram: Cycles 3, 6, 9,12,15,18,21,24
CT scan of chest, pelvis & abdomen: Cycles 7, 13, End of Treatment if extramedullary disease at baseline unresolved in previous CT scan
Standard of care bone marrow aspirate and biopsy: Cycles 7, 13, End of Treatment
Follow up every 12 wks for 4 yrs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Pirtobrutinib
2020
Completed Phase 1
~240
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,906 Total Patients Enrolled
28 Trials studying Waldenstrom Macroglobulinemia
2,732 Patients Enrolled for Waldenstrom Macroglobulinemia
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,518 Total Patients Enrolled
4 Trials studying Waldenstrom Macroglobulinemia
1,232 Patients Enrolled for Waldenstrom Macroglobulinemia
Jorge Castillo, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
13 Total Patients Enrolled
1 Trials studying Waldenstrom Macroglobulinemia
3 Patients Enrolled for Waldenstrom Macroglobulinemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I agree to use a condom during sex if my partner can have children.My organs and bone marrow are functioning normally.I am not taking strong medication that affects liver enzymes or drug transporters.You have a history of HIV or active CMV infection.I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed.I have been diagnosed with lymphoma in my central nervous system.I have been diagnosed with Waldenström Macroglobulinemia without MYD88 mutation.I have a serious heart condition.I have been treated with non-covalent BTK inhibitors before.I am currently on medication that suppresses my immune system.I am allergic to ingredients in pirtobrutinib or venetoclax.I am 18 years old or older.My condition requires treatment according to specific expert guidelines.I cannot take medications by mouth due to a digestive condition.I can swallow pills and can attend all required clinic visits and tests.My blood test shows high levels of IgM, more than twice the normal limit.I have an active autoimmune blood condition that needed new or more treatment in the last 4 weeks.I had severe bleeding or heart rhythm problems with a previous BTK inhibitor treatment.I do not have any ongoing serious infections.Your heart's electrical activity (QT interval) is too long on multiple ECG tests.I have received at least one treatment before.I am currently taking warfarin.I have not received any live vaccines in the last 4 weeks.I have not had major surgery in the last 4 weeks.You have a history of alcohol or drug abuse.You have a history of not following your doctor's instructions for taking medication.I have another cancer type, but it won't affect this trial's treatment.
Research Study Groups:
This trial has the following groups:- Group 1: PIRTOBRUTINIB + VENETOCLAX
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.
Has the combination of PIRTOBRUTINIB and VENETOCLAX been endorsed by the Food & Drug Administration?
"As this is a Phase 2 trial, the safety of PIRTOBRUTINIB + VENETOCLAX has been rated as a 2 based on existing data confirming its security but lacking proof for efficacy."
Answered by AI
Are there any openings remaining to participate in this research?
"Clinicaltrials.gov reveals that this clinical trial, initially posted on August 1st 2023 and last updated February 18th 2023 is no longer recruiting patients. Fortunately, there are 117 other studies actively searching for suitable participants at the moment."
Answered by AI
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