Rituximab + Venetoclax for Marginal Zone Lymphoma

Palo Alto (17 mi)

Overseen byAndrew Zelenetz, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study will help researchers understand how effective the combination of venetoclax and rituximab is in treating MZL in people who have not received a previous treatment for their cancer.

Eligibility Criteria

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.

Inclusion Criteria

I can swallow pills.

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

I am 18 years old or older.

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

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

My diagnosis is Marginal Zone Lymphoma.

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

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

Exclusion Criteria

I have been treated with ibrutinib or another BTK inhibitor before.

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

I have previously received systemic therapy, including rituximab.

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

Treatment Details

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.

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

Rituximab is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Rituxan for: