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BCL-2 Inhibitor
Zanubrutinib + Venetoclax for Chronic B-Cell Leukemia
Phase 2
Recruiting
Led By John Allan, M.D.
Research Sponsored by Weill Medical College of Cornell University
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 cycle 23 (month 23)
Awards & highlights
Study Summary
This trial tests if using two drugs, instead of three, to treat CLL/SLL patients reduces side effects and improves outcomes.
Who is the study for?
This trial is for adults with confirmed chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) who need treatment but haven't had any cancer therapy before. They must be able to follow pregnancy prevention measures if applicable. Exclusions include recent heart issues, severe infections, certain blood disorders, previous malignancies (except some skin cancers), and known allergies to the study drugs.Check my eligibility
What is being tested?
The trial tests a new approach using Zanubrutinib and Venetoclax pills as initial therapy for CLL, adding Obinutuzumab injections only if minimal residual disease is detected after treatment. The goal is to reduce unnecessary medication use while trying to increase the rate of no detectable cancer.See study design
What are the potential side effects?
Possible side effects from these medications may include diarrhea, bleeding problems, infections due to low white blood cell counts, fatigue, nausea or vomiting. Reactions at injection sites are also possible with Obinutuzumab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 23 (month 23)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 23 (month 23)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of eligible patients that have achieved undetectable minimal residual disease (MRD) at cycle 23, as assessed via bone marrow aspirate
Percentage of eligible patients that have achieved undetectable minimal residual disease (MRD) at cycle 23, as assessed via peripheral blood
Percentage of total patients that have achieved undetectable minimal residual disease (MRD) at cycle 16, as assessed via bone marrow aspirate
+1 moreSecondary outcome measures
36-month Overall Survival (OS)
36-month Progression Free Survival (PFS)
36-month Time to Next Treatment (TTNT)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Triple Therapy (Zanubrutinib, Venetoclax, and Obinutuzumab)Experimental Treatment3 Interventions
Participants that meet definition of MRD positivity at C16D1 will enter the triple therapy arm (zanubrutinib, venetoclax, and obinutuzumab). These participants will continue combination therapy with zanubrutinib and venetoclax, but will also receive 6 cycles of obinutuzumab starting at C17D1. In this subgroup, peripheral blood and bone marrow MRD assessments will occur after an additional 6 cycles of the triplet combination therapy (C23D1) at which point all participants will stop study treatment regardless of MRD status.
Group II: Double Therapy (Zanubrutinib plus Venetoclax)Experimental Treatment2 Interventions
All participants will receive an initial 3 cycles of zanubrutinib monotherapy. This lead-in period will then be followed by 12 cycles of zanubrutinib and venetoclax combination therapy. All participants will complete 12 cycles of zanubrutinib and venetoclax combination therapy or 15 cycles of total treatment. Peripheral blood and bone marrow MRD assessments will occur at C16D1. Participants will continue on double combination treatment for an additional 1 month while results of MRD testing are obtained. In total, all participants will be on treatment for at least 16 full cycles. Participants that meet definition of MRD negativity will stop therapy at C17D1 and enter an observation phase with study visits every 3 months. Participants that remain MRD positive at C16D1 will enter the triple therapy (zanubrutinib, venetoclax, and obinutuzumab) arm.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,245 Total Patients Enrolled
BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,775 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,093 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term medication to suppress my immune system or have been within the last 6 months.I have been diagnosed with CLL/SLL.I have or might have had PML in the past.I need treatment for my condition.I have not had a heart attack in the last 6 months.I have not received a live vaccine in the last 28 days.I had cancer other than non-melanoma skin cancer but have been free of it for 5 years.I have trouble swallowing pills or have a stomach condition that affects medication absorption.I have an active autoimmune blood disorder.I have a history of serious heart rhythm problems.I need warfarin or a similar medication.My condition is either prolymphocytic leukemia or Richter's Transformation.I am currently fighting a serious infection that needs treatment.I haven't had major surgery in the last 28 days.I have severe heart failure.I have had treatments like chemotherapy or immunotherapy for CLL/SLL.I have not had a stroke or brain bleed in the last 6 months.I have not had unstable chest pain in the last 3 months.I do not have active bleeding or a history of bleeding disorders like hemophilia.
Research Study Groups:
This trial has the following groups:- Group 1: Double Therapy (Zanubrutinib plus Venetoclax)
- Group 2: Triple Therapy (Zanubrutinib, Venetoclax, and Obinutuzumab)
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.
Is the concurrent use of Zanubrutinib and Venetoclax a secure option for individuals?
"The safety of the double therapy (zanubrutinib plus venetoclax) is estimated to be a 2, signifying that while there has been some data supporting its safety, no evidence exists in regards to efficacy."
Answered by AI
Are there still vacancies available in this research project?
"Official records on clinicaltrials.gov demonstrate that this medical research is not presently recruiting participants; the trial was first announced on March 1st 2023 and edited lastly in December 6th 2022. Despite its lack of current recruitment, there are 1521 alternative trials actively searching for patients currently."
Answered by AI
What are the foremost goals of this clinical evaluation?
"According to Genentech, Inc., the primary outcome for this study will be ascertained via peripheral blood tests and assessed over a 16 Cycle (23 Month) timeline. Additionally, Kaplan-Meier methods will be used to measure 36 month Overall Survival rates from first treatment day until death from any cause as determined at 36 Months. Furthermore, Tumor Lysis Syndrome (TLS) Risk Score changes between Baseline and Cycles 4 Day 1 assessment must also be reported in aggregate figures. Lastly, there is an aim to calculate the percentage of patients that have achieved undetectable minimal residual disease after 24 months when treated with zan"
Answered by AI
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