Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Gottfried von Keudell, MD PhD
Study ID
NCT06510309
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    B-cell lymphoma inhibitor, tablets taken orally per protocol.
  • Rituximab — DRUG
    Anti-CD20 monoclonal antibody, 10mL or 50 mL single-use vials, via intravenous (into the vein) infusion per protocol.

Study Details

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)

Key Dates

Start date
Feb 11, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2028
Completion
Oct 1, 2031

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab + Venetoclax
    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.

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Gottfried von Keudell, MD, PhD
[email protected]
617-667-9920
Dea Hunsicker, PhD
[email protected]
Gottfried von Keudell, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Beth Israel Deaconess Medical Center· Boston, MA

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