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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
Must not have
Unwilling or unable to participate in all required study evaluations and procedures
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am willing and able to follow all study requirements.
Select...
I understand the study's risks and can sign the consent form.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients able to remain off CLL/SLL directed therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Venetoclax with anti-CD20 monoclonal antibodyExperimental Treatment1 Intervention
Group II: Venetoclax monotherapyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,998 Total Patients Enrolled
158 Trials studying Lymphoma
9,319 Patients Enrolled for Lymphoma
Adaptive BiotechnologiesIndustry Sponsor
12 Previous Clinical Trials
3,537 Total Patients Enrolled
3 Trials studying Lymphoma
354 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
Meghan Thompson, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
155 Total Patients Enrolled
Lindsey Roeker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
155 Total Patients Enrolled

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
~5 spots leftby May 2025
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