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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 Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Able to swallow pills

Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm or spleen >13 cm

Must not have

Prior treatment with ibrutinib or other BTK inhibitor

Patients who received moderate or strong CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of venetoclax

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand if combining venetoclax with rituximab is effective in treating those with MZL who have not received prior treatment for their cancer.

Who is the study for?

Adults diagnosed with Marginal Zone Lymphoma (MZL) who haven't been treated before can join this trial. They must have normal organ function, measurable disease, and a life expectancy over two years. Those with certain hepatitis B conditions or controlled HIV are eligible. Pregnant women, those unwilling to use effective contraception post-treatment, or patients previously treated for MZL cannot participate.

What is being tested?

The study is testing the effectiveness of combining two drugs—Venetoclax and Rituximab—in treating MZL in new patients. It aims to understand how well these drugs work together as an initial treatment option for this type of lymphoma.

What are the potential side effects?

Potential side effects from Venetoclax and Rituximab may include infections due to a weakened immune system, infusion reactions during drug administration, liver problems, digestive issues like nausea or constipation, fatigue, and blood cell count changes.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow pills.

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

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I am 18 years old or older.

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I have gastric MALT lymphoma, am H. pylori negative or didn't respond to treatment, and can't or won't have radiation.

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

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My diagnosis is Marginal Zone Lymphoma.

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

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I have gastric MALT lymphoma and am not infected with H. pylori.

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 before.

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

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I have previously received systemic therapy, including rituximab.

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I do not have any severe illnesses that would stop me from following the study's requirements.

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

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

overall response rates (ORR)

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

SARS-CoV-2 test positive

11%

Sepsis

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

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 and VenetoclaxExperimental Treatment2 Interventions

Patients will be treated with an Induction phase of rituximab 375 mg/m2 weekly for 4 weeks. Patients will undergo restaging imaging after the last of 4 weekly rituximab doses and before beginning venetoclax. Based on post-rituximab restaging studies, patients will be risk-stratified for risk of Tumor Lysis Syndrome (TLS) and treated in the appropriate setting with TLS prophylaxis per institutional TLS guide lines starting at week 5. Oral venetoclax will follow a ramp-up dosing schedule and will be taken daily after 4 weeks of rituximab therapy. Following the 4-week ramped-up phase of venetoclax, patients will begin their target dose of venetoclax and continue for a maximum of 24 months. In addition, patients will receive rituximab 375 mg/m2 starting on day 1 of the maintenance phase and repeated once every 3 months for 12 months. Venetoclax may be continued after this period if patient has not achieved a complete remission

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2240

Rituximab

1999

Completed Phase 4

~2990