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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

complete response rate (CRR)

Secondary outcome measures

overall response rates (ORR)

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

Hypokalaemia

11%

Blood creatinine increased

11%

Neutrophil count decreased

11%

Pneumonia pseudomonal

11%

Rhinovirus infection

11%

White blood cell count decreased

11%

Dermatitis

11%

Pneumonia

11%

Abdominal pain

11%

Anaemia

11%

Sepsis

11%

Gastroenteritis

11%

SARS-CoV-2 test positive

11%

Electrocardiogram QT prolonged

11%

Febrile neutropenia

11%

COVID-19

11%

Supraventricular tachycardia

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

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

~1990

Rituximab

1999

Completed Phase 4

~1880

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,937 Previous Clinical Trials

588,314 Total Patients Enrolled

AbbVieIndustry Sponsor

962 Previous Clinical Trials

503,107 Total Patients Enrolled

Gottfried von Keudell, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Rituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04416451 — Phase 2

Marginal Zone Lymphoma Research Study Groups: Rituximab and Venetoclax

Marginal Zone Lymphoma Clinical Trial 2023: Rituximab Highlights & Side Effects. Trial Name: NCT04416451 — Phase 2

Rituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04416451 — Phase 2

Frequently Asked Questions

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

In how many different areas is this trial taking place?

"There are 11 sites associated with this trial, 8 of which are actively enrolling patients. These include Memorial Sloan Kettering Commack (All Protocol Activities) in Commack, Memoral Sloan Kettering Monmouth (All protocol activities) in Middletown, and City of Hope Cancer Center (Data collection only) in Duarte."

Answered by AI

Could you please evaluate the risks associated with Venetoclax?

"While there is some data supporting Venetoclax's safety, it has not been proven effective yet and thus only received a score of 2."

Answered by AI

What are some of the health conditions that Venetoclax is known to ameliorate?

"While diffuse large b-cell lymphoma (dlbcl) is the most common reason for Venetoclax treatment, this medication can also help patients manage b-cell lymphomas, polyangium, and pemphigus vulgaris."

Answered by AI

What other research has been done on Venetoclax?

"There are currently 617 clinical trials ongoing for Venetoclax. Of these, 118 have reached Phase 3. The vast majority of research locations for this treatment are based in Edmonton, Alberta; however, there are 20845 total sites running studies."

Answered by AI

How many test subjects are taking part in this clinical research?

"That is correct. The trial, which was initially posted on May 4th, 2021, appears to be actively recruiting patients according to the most recent update from September 13th, 2022. They are currently looking for 47 individuals across 8 different sites."

Answered by AI

Are investigators looking for new participants at this time?

"According to the clinicaltrials.gov listing, this study is still enrolling patients. The posting went up on 5/4/2021 and was edited as recently as 9/13/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma

2021. "A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04416451.

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