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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
2014
Completed Phase 3
~3470
Venetoclax
2019
Completed Phase 3
~2200
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
85 Previous Clinical Trials
26,234 Total Patients Enrolled
42 Trials studying Leukemia
12,961 Patients Enrolled for Leukemia
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,641 Total Patients Enrolled
461 Trials studying Leukemia
31,741 Patients Enrolled for Leukemia
Loxo Oncology, Inc.Industry Sponsor
69 Previous Clinical Trials
10,242 Total Patients Enrolled
8 Trials studying Leukemia
3,017 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.
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