Actively Recruiting
Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma
Led by Gottfried von Keudell, MD PhD · Updated on 2026-03-13
33
Participants Needed
1
Research Sites
294 weeks
Total Duration
On this page
Sponsors
G
Gottfried von Keudell, MD PhD
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed Marginal Zone Lymphoma
- Patients must have measurable disease with at least one lymph node 1.5 cm or spleen larger than 13 cm
- Patients with intestinal MALT lymphoma must have disease detectable by EGD or colonoscopy with biopsy
- Patients with gastric MALT lymphoma must be Helicobacter pylori negative or have failed H. pylori eradication therapy
- Patients with gastric MALT lymphoma who are H. pylori negative or have relapsed/refractory disease after eradication must have refused or failed gastric radiation therapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 2 years
- Adequate organ and marrow function defined by hemoglobin 2 g/dL, absolute neutrophil count 1,000 cells/mcL (or 1,500 if bone marrow involved), platelets 50,000 cells/mm3, total bilirubin less than 1.5 times institutional upper limit of normal (ULN) (up to 3 times ULN for Gilbert's disease or liver involvement), AST and ALT less than 3 times ULN unless caused by liver involvement, and creatinine within ULN or creatinine clearance greater than 60 mL/min
- Ability to understand and willingness to sign informed consent
- Ability to swallow pills
- HIV-positive patients on stable combination antiretroviral therapy with CD4 count greater than 300
- Patients with Hepatitis B surface antibody positivity or Hepatitis B core antibody positivity with negative PCR on antiviral therapy are eligible
You will not qualify if you...
- Prior systemic therapy including rituximab
- Prior radiation therapy except palliative radiotherapy or prior RT for gastric MALT lymphoma completed at least 1 week before study treatment
- Prior treatment with ibrutinib or other BTK inhibitors
- Patients with H. pylori-associated gastric MALT or stage I/II MZL unless unfit for curative radiation therapy
- Uncontrolled illnesses including active infection, congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting compliance
- Uncontrolled hepatitis B or C or HIV infection defined by positive serologies and detectable viral load
- Pregnant or breastfeeding women or those unwilling to use effective contraception for 12 months after last rituximab dose
- Recent use (within 7 days) of moderate or strong CYP3A inhibitors or inducers prior to first dose of venetoclax
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
G
Gottfried von Keudell, MD, PhD
CONTACT
D
Dea Hunsicker, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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