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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 below

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I am 18 years old or older.

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I have been diagnosed with CLL, SLL, or MCL according to WHO standards.

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I can take care of myself and am up and about more than half of my waking hours.

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I agree not to donate sperm or eggs during and up to 18 months after treatment.

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My blood test shows at least 1% of my white blood cells are CLL-like.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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

~1990

0 / 6Eligibility criteria met

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

1,936 Previous Clinical Trials

588,668 Total Patients Enrolled

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03824483 — Phase 2

Chronic Lymphocytic Leukemia Research Study Groups: BOVEN regimen

Chronic Lymphocytic Leukemia Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT03824483 — Phase 2

Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03824483 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study popular in North America?

"There are 8 medical centres conducting this trial. These locations include Memorial Sloan Kettering Westchester in Harrison, Memorial Sloan Kettering Cancer Center in New york, and Massachusetts General Hospital (Data Collection and Specimen Analysis) in Boston."

Answered by AI

Are there any risks associated with Venetoclax?

"While there is some data supporting its safety, Venetoclax received a score of 2 because this is only a Phase 2 trial and no efficacy has been proven yet."

Answered by AI

What are some common reasons why Venetoclax is given to patients?

"Venetoclax is not only useful for treating small lymphocytic lymphoma, but can also be employed when managing lymphoid leukemia and certain types of lymphoma."

Answered by AI

What is the total number of participants for this research?

"Yes, clinicaltrials.gov currently lists this trial as active and recruiting patients. The study was first posted on February 22nd, 2019, and was most recently updated on September 9th, 2022. They are looking for a total of 127 participants across 8 different locations."

Answered by AI

What are some previous examples of research using Venetoclax?

"Venetoclax was first studied in 2012 at CHU de Dijon. As of now, 118 clinical trials have been completed while 323 are still ongoing. Many of the active studies are based out of Harrison, New york."

Answered by AI

Can patients still sign up for this trial?

"The clinical trial is currently looking for 127 patients at 8 different sites, according to the latest data from clinicaltrials.gov. This study was originally posted on February 22nd, 2019 and was most recently updated on September 9th, 2020."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

Zanubrutinib, Obinutuzumab, and Venetoclax with Minimal Residual Disease-driven Discontinuation in Previously Untreated Patients with Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma: A Multicentre, Single-arm, Phase 2 Trial

Soumerai, Jacob D, Anthony R Mato, Ahmet Dogan, Venkatraman E Seshan, Erel Joffe, Kelsey Flaherty, Jason Carter, et al.. 2021. “Zanubrutinib, Obinutuzumab, and Venetoclax with Minimal Residual Disease-driven Discontinuation in Previously Untreated Patients with Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma: A Multicentre, Single-arm, Phase 2 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(21)00307-0.

clinicaltrials.govStudy

Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)

2019. "Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03824483.

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