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Monoclonal Antibodies

Venetoclax for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Anthony Mato, MD

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

Patients must have achieved a complete or partial remission with the venetoclax-based regimen. Criteria for remission are per iwCLL 2018 guidelines. For this protocol, bone marrow biopsy/aspirate evaluation is not necessary to determine remission status.

Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma confirmed by the enrolling institution

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study whether people with CLL/SLL who have responded to treatment with venetoclax can stop treatment and remain off-treatment for a year or more.

Who is the study for?

Adults diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma, who have had a positive response to venetoclax treatment and show no minimal residual disease. They must have completed any anti-CD20 monoclonal antibody treatments and been on venetoclax for at least 6 months.Check my eligibility

What is being tested?

The trial is testing if people with CLL or SLL who are MRD-negative after venetoclax treatment can stop taking the drug without their disease returning within 12 months. It also checks if they stay MRD-negative post-treatment.See study design

What are the potential side effects?

While not specified here, common side effects of Venetoclax include diarrhea, nausea, low white blood cell count (neutropenia), upper respiratory tract infection, fatigue, and cough.

Eligibility Criteria

Inclusion Criteria

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

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I have had a complete or partial recovery from my condition with venetoclax treatment.

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My diagnosis is chronic lymphocytic leukemia or small lymphocytic lymphoma.

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I can provide a sample for future cancer monitoring tests.

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I have been on venetoclax-based therapy for at least 6 months.

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I am 18 years old or older.

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My cancer affects my blood, bone marrow, or lymph nodes and requires fresh sample collection.

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I will start or am on a venetoclax-based treatment soon.

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I am currently on Venetoclax treatment alone.

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I completed treatment with an anti CD20 antibody before stopping therapy.

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I have had two negative blood tests for minimal residual disease, at least 28 days apart.

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I have finished or stopped the anti-CD20 antibody part of my treatment before stopping therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients able to remain off CLL/SLL directed therapy

Trial Design

2Treatment groups

Experimental Treatment

Group I: Venetoclax with anti-CD20 monoclonal antibodyExperimental Treatment1 Intervention

Group II: Venetoclax monotherapyExperimental Treatment1 Intervention

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,724 Total Patients Enrolled

155 Trials studying Lymphoma

8,668 Patients Enrolled for Lymphoma

Adaptive BiotechnologiesIndustry Sponsor

11 Previous Clinical Trials

3,596 Total Patients Enrolled

2 Trials studying Lymphoma

350 Patients Enrolled for Lymphoma

Anthony Mato, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

6 Previous Clinical Trials

211 Total Patients Enrolled

2 Trials studying Lymphoma

5 Patients Enrolled for Lymphoma

Media Library

Anti CD20 Monoclonal Antibody (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04419519 — Phase 2

Lymphoma Research Study Groups: Venetoclax with anti-CD20 monoclonal antibody, Venetoclax monotherapy

Lymphoma Clinical Trial 2023: Anti CD20 Monoclonal Antibody Highlights & Side Effects. Trial Name: NCT04419519 — Phase 2

Anti CD20 Monoclonal Antibody (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04419519 — Phase 2

Frequently Asked Questions

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

How many distinct sites are managing this research study?

"This medical study is actively recruiting participants from 10 distinct clinics, including those in Uniondale, New york City and Commack. To reduce the need for long-distance travel it would be beneficial to register at a nearby site."

Answered by AI

Is this research recruiting new participants at the moment?

"Affirmative. Per clinicaltrials.gov, this study is currently enrolling participants with a first post date of May 13th 2020 and last updated on March 15th 2022. 80 patients need to be recruited from 10 different medical locations."

Answered by AI

What research has been conducted regarding the use of Venetoclax as a single-agent treatment?

"In 2014, M D Anderson Cancer Center pioneered research into venetoclax monotherapy, with 51 completed studies since then. Currently there are 219 active investigations in this area of medicine and many of these trials take place at Commack, New york."

Answered by AI

Has Venetoclax received regulatory clearance when used on its own?

"Our team at Power gave Venetoclax monotherapy a score of 2 because the Phase two trial has not yet demonstrated efficacy, although there are some data points supporting safety."

Answered by AI

How many participants have been recruited for this trial thus far?

"Indeed, information on clinicaltrials.gov attests to this trial's current recruitment status. It was initially posted on May 13th 2020 and last updated on March 15th 2022, looking for 80 participants from 10 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax

2020. "Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04419519.

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