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Monoclonal Antibodies

Zanubrutinib + Rituximab for Chronic Lymphocytic Leukemia

Phase 2
Recruiting
Led By Jan A Burger
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients must have a diagnosis chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and be previously untreated
Must not have
Pregnant or breast-feeding females
Patients with severe hematopoietic insufficiency, as defined by an absolute neutrophil count of less than 500/uL, unless disease-related, and/or a platelet count of less than 30,000/uL at time of screening for this protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months after discontinuation of zanubrutinib
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination drug therapy for people with leukemia or lymphoma who haven't received treatment before. The therapy consists of two drugs: zanubrutinib and rituximab. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The study is being done to find out if zanubrutinib combined with rituximab can help control previously untreated chronic lymphocytic leukemia or small lymph

Who is the study for?
Adults with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma, who are generally healthy and not pregnant. They should be able to perform daily activities with ease to moderate difficulty (ECOG 0-2), have normal liver and kidney function tests, and no recent history of other cancers except certain skin cancers or localized cancer that has been treated.
What is being tested?
The trial is testing the combination of zanubrutinib, an enzyme blocker, and rituximab, a monoclonal antibody against previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. The goal is to see if this drug combo can control these blood cancers effectively.
What are the potential side effects?
Possible side effects include reactions at the infusion site from rituximab, increased risk of infections due to immune system suppression by both drugs, liver problems from zanubrutinib, fatigue, and potentially serious bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of the day.
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I have been diagnosed with CLL/SLL and have not received any treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently pregnant or breastfeeding.
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My blood tests show very low white blood cells or platelets.
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I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.
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I have active hepatitis B or C.
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I do not have an ongoing infection that isn't responding to treatment.
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I have uncontrolled autoimmune blood disorders that are worsening quickly.
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I do not have severe diseases or organ problems that could make treatment risky.
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I have previously been treated with drugs like zanubrutinib or ibrutinib.
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I have a serious wound or fracture that is not healing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months after discontinuation of zanubrutinib
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after discontinuation of zanubrutinib for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Success rate
Secondary study objectives
Clinical factors associated with a treatment-free remission of more than 6 months after discontinuation of zanubrutinib
Overall response
Treatment-free remission length

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: Treatment (zanubrutinib, rituximab)Experimental Treatment2 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2990
Zanubrutinib
2017
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,266 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,142 Total Patients Enrolled
Jan A BurgerPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
126 Total Patients Enrolled

Media Library

Rituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04458610 — Phase 2
CLL/SLL Research Study Groups: Treatment (zanubrutinib, rituximab)
CLL/SLL Clinical Trial 2023: Rituximab Highlights & Side Effects. Trial Name: NCT04458610 — Phase 2
Rituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04458610 — Phase 2
~14 spots leftby May 2026
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