NCT06510309 Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma
| NCT ID | NCT06510309 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Gottfried von Keudell, MD PhD |
| Condition | Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2026-02-11 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 33 participants in total. It began in 2026-02-11 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
Inclusion Criteria: * 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 * Patients with intestinal MALT lymphoma must have disease that is detectable by EGD or colonoscopy with biopsy * Patients with gastric MALT lymphoma must be h. pylori negative. Patients who are h. pylori positive are allowed if they have failed a trial of h. pylori eradication * Patients with gastric MALT lymphoma who are h. pylori negative or who relapsed/refractory disease after h. pylori eradication must be ineligible form have refused or failed gastric radiation therapy * Age ≥18 years * ECOG performance status ≤1 * Life expectancy of greater than 2 years * Participants must meet the following organ and marrow function as defined below: * Hemoglobin ≥8.0 g/dL * absolute neutrophil count ≥1,000 cells/mcL (In the event of documented bone marrow involvement, ANC must be ≥1500 cells/mcL) * platelets ≥50,000 cells/mm3 * total bilirubin \< 1.5 x institutional upper limit of normal (ULN) (In patients with Gilberts disease or documented liver involvement, total bilirubin \< 3 X ULN will be allowed) * AST(SGOT)/ALT(SGPT) \< 3 × institutional ULN unless elevation is caused by liver involvement with MZL * Creatinine within institutional ULN OR creatinine clearance \>60mL/min for patients with creatinine levels above institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine clearance measurements) * Ability to understand and the willingness to sign a written informed consent document * Patient must be able to swallow pills * HIV-positive patients on combination antiretroviral therapy are eligible if their HIV is under adequate control with an antiretroviral regimen that has been stable for \> 4 weeks, as long as the CD4 count is \>300. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated * Patients with Hepatitis B surface antibody serum positivity due to poor immunization, as well as those with Hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible Exclusion Criteria: * Patients who had prior systemic therapy including rituximab * Patients who have had prior radiation therapy, with the following exceptions: * Palliative radiotherapy (RT) is allowed, but must be completed at least 1 week prior to treatment on this study, and prior to any baseline imaging studies or biopsies. Patients must meet criteria for measurable/assessable disease as outlined above after completion of RT. * Prior RT for gastric MALT is allowed, but must be completed at least 1 week prior to treatment on this study, and prior to any baseline imaging studies or biopsies. Patients must meet criteria for measurable/assessable disease as outlined above after completion of RT. * Prior treatment with ibrutinib or other BTK inhibitor * Patients with h. pylori-associated gastric MALT or stage I/II MZL will be excluded unless they are deemed to be unfit for radiation therapy with curative intent. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients with uncontrolled hepatitis B or C or HIV infection are ineligible defined as patients with positive serologies and a detectable viral load by PCR. * Patients with Hep B core ab positivity are allowed provided Hep B PCR is undetectable * Pregnant women or participants unwilling to adhere to institutional guidelines for highly effective contraception for 12 months after the last dose of rituximab are excluded from this study because of documented risks of rituximab on fetal immunologic development and unknown effects of venetoclax on embryonic development. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued. * Received moderate or strong CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of venetoclax. * Received moderate or strong CYP3A inducers (such as rifampin, carbamazepine, phenytoin, St. John's Wort) within 7 days prior to the first dose of venetoclax.
Contact & Investigator
Gottfried von Keudell, MD, PhD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT06510309 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06510309 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06510309 currently recruiting?
Yes, NCT06510309 is actively recruiting participants. Contact the research team at gkeudell@bidmc.harvard.edu for enrollment information.
Where is the NCT06510309 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06510309 clinical trial?
NCT06510309 is sponsored by Gottfried von Keudell, MD PhD. The principal investigator is Gottfried von Keudell, MD, PhD at Beth Israel Deaconess Medical Center. The trial plans to enroll 33 participants.