Your session is about to expire
← Back to Search
Monoclonal Antibodies
Triple Combo Therapy for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Andrew Zelenetz, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Diagnosis of the following histories according to the WHO criteria: CLL or SLL, MCL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new combo treatment for CLL/SLL to see how effective it is at getting rid of disease.
Who is the study for?
Adults diagnosed with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), who haven't had systemic therapy for these conditions, can join. They should be in a stable health condition and willing to use effective contraception. People with other active cancers, serious infections, or certain heart/liver diseases cannot participate.Check my eligibility
What is being tested?
The trial is testing the combination of three drugs: Zanubrutinib, Obinutuzumab, and Venetoclax in patients with CLL/SLL. The goal is to see if this drug combo can eliminate all detectable traces of the disease from the body.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as infusion reactions, bleeding issues due to blood disorders, liver problems, infections due to weakened immunity and may affect fertility.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with CLL, SLL, or MCL according to WHO standards.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I agree not to donate sperm or eggs during and up to 18 months after treatment.
Select...
My blood test shows at least 1% of my white blood cells are CLL-like.
Select...
My kidney and liver tests are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
establish the rate of minimum residual disease (MRD) undetectable response
Trial Design
1Treatment groups
Experimental Treatment
Group I: BOVEN regimenExperimental Treatment3 Interventions
Patients will be given zanubrutinib (160mg by mouth BID) and obinutuzumab (1000mg IVPB on Days 1*, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8) starting on Cycle 1 (28-day cycles). * On Cycle 1, obinituzumab will be administered in "split dose" at 100mg IVPB on Day 1 and 900mg IVPB on Day 2 in patients at increased risk for IRR (ALC >25,000 cells/ul or baseline lymph nodes >5 cm diameter). Venetoclax will be added to the regimen starting on Cycle 3, and will be incorporated into the regimen using the 5-week ramp-up schedule to mitigate the risk of tumor lysis syndrome (beginning at 20mg and gradually increasing to 400mg), and venetoclax will be administered a ta fixed dose level of 400mg by mouth daily of 28-day cycles thereafter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~1940
Obinutuzumab
2015
Completed Phase 3
~3250
Venetoclax
2019
Completed Phase 3
~1950
Find a Location
Who is running the clinical trial?
Roche-GenentechIndustry Sponsor
24 Previous Clinical Trials
3,455 Total Patients Enrolled
BeiGene USA, Inc.Industry Sponsor
2 Previous Clinical Trials
194 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,662 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have been diagnosed with CLL, SLL, or MCL according to WHO standards.My blood counts are within normal ranges, unless affected by my condition.I can take care of myself and am up and about more than half of my waking hours.I haven't had systemic therapy for my condition, but I may have had radiation or short-term steroids.I agree to use contraception or abstain from sex during and up to 18 months after treatment.I haven't had any other cancers or treatments for them in the last 3 years, except for local treatments aimed at cure.I agree to use effective birth control or remain abstinent during and after treatment as required.I agree not to donate sperm or eggs during and up to 18 months after treatment.I haven't taken strong medication inhibitors, live vaccines, or specific foods recently.My condition is TP53 mutant mantle cell lymphoma.I have had anti-CD20 therapy for a non-cancer condition and am not allergic to Obinutuzumab.My blood test shows at least 1% of my white blood cells are CLL-like.My kidney and liver tests are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: BOVEN regimen
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger