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Monoclonal Antibodies

Zanubrutinib + Obinutuzumab + Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia

Memorial Sloan Kettering Monmouth, Middletown, NJ

Targeting 2 different conditionsZanubrutinib +2 morePhase 2RecruitingLed by Andrew Zelenetz, MD, PhDResearch 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

Signed, informed consent

ECOG performance status of 0 to 2

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up1 year

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing a new combo treatment for CLL/SLL to see how effective it is at getting rid of disease.

Eligible Conditions

Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 2

~1270

Obinutuzumab

2015

Completed Phase 3

~3250

Venetoclax

2019

Completed Phase 3

~2100

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,911 Previous Clinical Trials

588,721 Total Patients Enrolled

BeiGene USA, Inc.Industry Sponsor

2 Previous Clinical Trials

194 Total Patients Enrolled

Roche-GenentechIndustry Sponsor

23 Previous Clinical Trials

3,288 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 n New Yo ing 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 c 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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