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Monoclonal Antibodies

Rituximab + Venetoclax for Marginal Zone Lymphoma

Phase 2

Waitlist Available

Led By Gottfried von Keudell, MD, PhD

Research Sponsored by Gottfried von Keudell, MD PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with intestinal MALT lymphoma must have disease that is detectable by EGD or colonoscopy with biopsy

Participants must have histologically confirmed Marginal Zone Lymphoma

Must not have

Prior treatment with ibrutinib or other BTK inhibitor

Patients who had prior systemic therapy including rituximab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if a combination of rituximab and venetoclax is effective in treating individuals with untreated Marginal Zone Lymphoma (MZL). Venetoclax is

Who is the study for?

This trial is for individuals with untreated Marginal Zone Lymphoma (MZL), a type of lymphoma. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments.

What is being tested?

The study is testing the effectiveness of combining two drugs, Venetoclax and Rituximab, in treating MZL. Venetoclax is an inhibitor that targets cancer cells, while Rituximab is an antibody that helps the immune system attack cancer.

What are the potential side effects?

Possible side effects from Venetoclax include diarrhea, nausea, low blood cell counts increasing infection risk, and fatigue. Rituximab can cause infusion reactions, infections due to weakened immunity, heart issues and skin rashes.

Eligibility Criteria

Inclusion Criteria

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

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My intestinal MALT lymphoma is confirmed by a scope and biopsy.

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My diagnosis is Marginal Zone Lymphoma confirmed by tissue analysis.

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I have a lymph node larger than 1.5 cm or a spleen larger than 13 cm.

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I have gastric MALT lymphoma, am H. pylori negative, or my disease didn't improve after H. pylori treatment and I can't or won't have gastric radiation.

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I am 18 years old or older.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with ibrutinib or another BTK inhibitor.

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I have received rituximab or similar treatments before.

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I haven't taken strong medications like fluconazole within the last week.

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I do not have any serious illnesses that could interfere with the study.

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I do not have uncontrolled hepatitis B, C, or HIV with a detectable viral load.

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I am not pregnant and agree to use effective birth control for 12 months after my last rituximab dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response Rate (CRR)

Secondary study objectives

Duration of Response (DOR)

Median Event Free Survival (EFS)

Median Overall Survival (OS)

+3 more

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: Rituximab + VenetoclaxExperimental Treatment2 Interventions

33 participants will be enrolled and will complete study procedures as follows: * Baseline visit with screening assessments, scans, and tumor and bone marrow biopsies. * Induction Period: * CT/MRI scans at week 4. * Weeks 1 - 4: Predetermined dose of Rituximab 1x weekly. * Weeks 5 - 8: Predetermined dose of Venetoclax 1x daily. * Maintenance Period: * CT/MRI scan on weeks 12, 36, 60, 84, and then every 6 months after week 96. * Predetermined dose of Venetoclax 1x daily for up to week 96, then once every 6 months. * Predetermined dose of Rituximab 1x weekly at weeks 12, 24, 36, and 48. * End of Treatment Visit: CT/MRI scan, tumor biopsy, and bone marrow biopsy. * Follow up: In-clinic visit at 1 year after finishing study drugs.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Venetoclax

2019

Completed Phase 3

~2240