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Monoclonal Antibodies

Rituximab + Venetoclax for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Led By Gottfried von Keudell, MD, PhD
Research Sponsored by Gottfried von Keudell, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participants must have histologically confirmed Marginal Zone Lymphoma
* 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 up to 36 months
Awards & highlights

Summary

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)

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from Venetoclax include diarrhea, nausea, low blood cell counts increasing infection risk, and fatigue. Rituximab can cause infusion reactions, infections due to weakened immunity, heart issues and skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Response Rate (CRR)
Secondary study objectives
Duration of Response (DOR)
Median Event Free Survival (EFS)
Median Overall Survival (OS)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rituximab + VenetoclaxExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Rituximab
1999
Completed Phase 4
~2200

Find a Location

Who is running the clinical trial?

Gottfried von Keudell, MD PhDLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
AbbVieIndustry Sponsor
1,002 Previous Clinical Trials
513,025 Total Patients Enrolled
Gottfried von Keudell, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
2 Previous Clinical Trials
106 Total Patients Enrolled
~22 spots leftby Feb 2025
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