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Monoclonal Antibodies
Triple Therapy for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Nitin Jain, 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
Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
Adequate hematologic function: Platelet count ≥50 x109/L and hemoglobin ≥ 8 g/dL. Absolute neutrophil count ≥ 0.75 x 109/L
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 1 year.
Awards & highlights
Study Summary
This trial will test if a combination of pirtobrutinib, venetoclax, and obinutuzumab is safe and effective for patients with CLL or RT who haven't had previous treatment.
Who is the study for?
This trial is for adults with untreated chronic lymphocytic leukemia (CLL) or Richter transformation (RT). Participants must have certain levels of bilirubin, renal function, and blood counts. They should not have active hepatitis B/C, HIV, uncontrolled infections or autoimmune diseases requiring high-dose steroids. Pregnant women are excluded and participants must agree to use effective contraception.Check my eligibility
What is being tested?
The study tests a combination of three drugs: Pirtobrutinib, Venetoclax, and Obinutuzumab in patients who haven't been treated before for CLL or RT. It aims to determine the safety and effectiveness of this drug regimen.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site from Obinutuzumab; diarrhea, nausea from Venetoclax; bleeding risks from Pirtobrutinib; as well as general side effects like fatigue and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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My blood tests show enough platelets, hemoglobin, and neutrophils.
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My kidneys work well, with a creatinine clearance rate of 50 ml/min or more.
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I am 18 years old or older.
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My liver tests are within the required range.
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
The severity of the adverse events (AEs) will be graded according to the U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pirtobrutinib plus Venetoclax plus Obinutuzumab (combination)Experimental Treatment5 Interventions
Participants will receive the study drugs in cycles. Each cycle is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240
Obinutuzumab
2015
Completed Phase 3
~3250
Venetoclax
2019
Completed Phase 3
~1990
Valacyclovir
2008
Completed Phase 4
~2520
Allopurinol
1999
Completed Phase 4
~6150
Find a Location
Who is running the clinical trial?
The Leukemia and Lymphoma SocietyOTHER
80 Previous Clinical Trials
16,914 Total Patients Enrolled
41 Trials studying Leukemia
3,931 Patients Enrolled for Leukemia
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,305 Total Patients Enrolled
451 Trials studying Leukemia
31,440 Patients Enrolled for Leukemia
Loxo Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
9,809 Total Patients Enrolled
8 Trials studying Leukemia
3,056 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects how my body absorbs medication.I am 18 years old or older.My blood tests show enough platelets, hemoglobin, and neutrophils.My kidneys work well, with a creatinine clearance rate of 50 ml/min or more.I have a serious heart condition that is not under control.I have untreated CLL/SLL needing treatment or treated/untreated RT from CLL.I have not had major surgery in the last 4 weeks.My liver tests are within the required range.I am not pregnant and agree to use birth control during and 6 months after the study.I am not taking medication that strongly affects liver enzyme CYP3A4.I do not have an ongoing serious infection.I need more than 20 mg of prednisone daily for my autoimmune condition.I am able to care for myself and perform daily activities.I agree to use effective birth control during and for 6 months after the study.I can take pills and attend all clinic visits and tests for the study.I haven't received any live-virus vaccines in the last 4 weeks.I am currently taking warfarin or a similar blood thinner.I have a history of unusual bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Pirtobrutinib plus Venetoclax plus Obinutuzumab (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.
Has the FDA approved Pirtobrutinib for clinical use?
"Based on available evidence from Phase 2 trials, Pirtobrutinib was assigned a score of two for its safety. This is because there has been some confirmation about its security but no data to demonstrate efficacy yet."
Answered by AI
Are there any vacancies remaining in this clinical trial?
"According to clinicaltrials.gov, this trial is no longer recruiting participants; the original advertisement was posted on February 28th 2023 and the last update occurred September 28th 2022. Nevertheless, there are currently 1516 active studies seeking enrollees."
Answered by AI
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