Rituximab + Venetoclax for Marginal Zone Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen by Gottfried von Keudell, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Gottfried von Keudell, MD PhD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating participants with untreated Marginal Zone Lymphoma (MZL). The names of the study drugs involved in this study are: * Venetoclax (a type of inhibitor) * Rituximab (a type of antibody)

Research Team

Gottfried von Keudell, MD, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Hemoglobin ≥8.0 g/dL

Platelets ≥50,000 cells/mm3

My liver enzymes are within normal limits, unless due to my cancer.

Exclusion Criteria

I am not eligible for radiation therapy aimed at curing early-stage stomach lymphoma linked to H. pylori.

I have been treated with ibrutinib or another BTK inhibitor.

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

Treatment Details

Interventions

• Rituximab (Monoclonal Antibodies)
• Venetoclax (BCL-2 Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Rituximab + Venetoclax Experimental Treatment 2 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.

Rituximab is already approved in Canada for the following indications:

Approved in Canada as Rituxan for:

• Non-Hodgkin's lymphoma
• Chronic lymphocytic leukemia
• Rheumatoid arthritis
• Granulomatosis with polyangiitis
• Microscopic polyangiitis

Who Is Running the Clinical Trial?

Gottfried von Keudell, MD PhD

Lead Sponsor

Trials

2

Recruited

50+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois