6 Participants Needed

Rituximab + Venetoclax for Marginal Zone Lymphoma

Recruiting at 9 trial locations
Gv
AZ
GS
Overseen ByGilles Salles, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically moderate or strong CYP3A inhibitors and inducers, at least 7 days before starting venetoclax. If you're on these medications, you may need to discuss alternatives with your doctor.

What makes the drug combination of Rituximab and Venetoclax unique for treating Marginal Zone Lymphoma?

The combination of Rituximab and Venetoclax is unique because it leverages the synergistic effect of these two drugs, which has been shown to significantly prolong progression-free survival in similar conditions like chronic lymphocytic leukemia. Venetoclax is a BCL-2 inhibitor that helps induce cancer cell death, while Rituximab is a monoclonal antibody that targets CD20 on B-cells, making this combination a novel approach compared to traditional therapies.12345

What data supports the effectiveness of the drug combination Rituximab and Venetoclax for treating Marginal Zone Lymphoma?

Research shows that the combination of Venetoclax and Rituximab is effective in treating chronic lymphocytic leukemia (CLL), with studies indicating that this combination can significantly prolong the time patients live without their disease getting worse. This suggests potential benefits for similar conditions like Marginal Zone Lymphoma.12356

Who Is on the Research Team?

AZ

Andrew Zelenetz, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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

Patients must have normal organ function as defined below: Platelet count ≥ 50,000 cells/mm^3, Hemoglobin ≥ 8.0 g/dL, Absolute neutrophil count ≥ 1000 cells/mcL. If there is documented bone marrow involvement, ANC must be >/= 500 cells/mcL, Total bilirubin < 1.5 x upper normal institutional limits. In patients with Gilbert's disease or documented liver involvement, total bilirubin up to 3x ULN will be allowed, AST(SGOT)/ALT(SGPT) <3 x institutional upper limit of normal unless elevation is caused by liver involvement with MZL, Creatinine clearance >60 mL/min for patients with creatinine levels above institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine clearance measurements)
I have been vaccinated for Hepatitis B or have it under control with negative PCR results.
I can swallow pills.
See 10 more

Exclusion Criteria

I have been treated with ibrutinib or another BTK inhibitor before.
I have Hepatitis B but my viral load is undetectable.
I haven't taken strong medications like fluconazole within the last week.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive rituximab 375 mg/m2 weekly for 4 weeks, followed by restaging imaging and risk stratification for Tumor Lysis Syndrome (TLS)

4 weeks

Ramp-up

Oral venetoclax is administered with a ramp-up dosing schedule for 4 weeks

4 weeks

Maintenance

Patients continue venetoclax for up to 24 months and receive rituximab every 3 months for 12 months

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rituximab
  • Venetoclax
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Rituximab and VenetoclaxExperimental Treatment2 Interventions

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

🇺🇸
Approved in United States as Rituxan for:
🇪🇺
Approved in European Union as MabThera for:
🇨🇦
Approved in Canada as Rituxan for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

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 profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a study involving 10 patients with relapsed/refractory chronic lymphocytic leukemia (CLL), the addition of rituximab to venetoclax therapy resulted in a 50% response rate, with three patients achieving complete responses and two achieving partial responses.
The combination treatment was well tolerated, suggesting that adding rituximab after progression on venetoclax may provide a beneficial option for some patients with R/R CLL.
Addition of rituximab in relapsed/refractory chronic lymphocytic leukemia after progression on venetoclax monotherapy.Handunnetti, S., Anderson, MA., Roberts, AW., et al.[2022]
In a study of 323 patients with relapsed or refractory chronic lymphocytic leukemia (CLL), a daily dose of 400 mg of venetoclax resulted in a median progression-free survival (PFS) of 1.8 years.
The addition of 6 cycles of rituximab to venetoclax treatment significantly increased the median PFS to 3.9 years, demonstrating a synergistic effect that enhances treatment efficacy beyond increasing the venetoclax dose alone.
Relationship between venetoclax exposure, rituximab coadministration, and progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia: demonstration of synergy.Freise, KJ., Jones, AK., Menon, RM., et al.[2018]
The combination of venetoclax with rituximab showed remarkable efficacy and a manageable safety profile in treating chronic lymphocytic leukemia (CLL), both in relapsed/refractory cases and as a first-line therapy for high-risk patients.
Similarly, the combination of ibrutinib with venetoclax also demonstrated striking efficacy, suggesting that these combinations could become new standard treatment options for CLL.
Chronic lymphocytic leukemia at ASH 2017.Wanner, D., Steurer, M.[2020]

Citations

Addition of rituximab in relapsed/refractory chronic lymphocytic leukemia after progression on venetoclax monotherapy. [2022]
Relationship between venetoclax exposure, rituximab coadministration, and progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia: demonstration of synergy. [2018]
Chronic lymphocytic leukemia at ASH 2017. [2020]
Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia . [2018]
Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia. [2020]
Venetoclax, bendamustine, and rituximab in patients with relapsed or refractory NHL: a phase Ib dose-finding study. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security