A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma

Gottfried von Keudell, MD PhD1 个研究点分布在 1 个国家目标入组 33 人2026年2月11日

适应症Lymphoma Marginal Zone Lymphoma MZL

干预措施Venetoclax Rituximab

概览

阶段: 2 期
干预措施: Venetoclax
疾病 / 适应症: Lymphoma
发起方: Gottfried von Keudell, MD PhD
入组人数: 33
试验地点: 1
主要终点: Complete Response Rate (CRR)
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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)

详细描述

This is a phase II study of rituximab plus venetoclax in participants with MZL who have not had prior chemotherapy. The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating Marginal Zone Lymphoma. The U.S. Food and Drug Administration (FDA) has not approved venetoclax for MZL but it has been approved for other uses. The FDA has approved rituximab as a treatment option for MZL. The research study procedures include screening for eligibility, study treatment visits, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, blood tests, bone marrow and tumor biopsies, and electrocardiograms. Participants will receive study treatment for up to 24 months and will be followed for 1 year after discontinuation of the study drugs. It is expected that about 33 people will take part in this research study. Abbvie, Inc. is funding this research study by providing venetoclax.

注册库

clinicaltrials.gov

开始日期

2026年2月11日

结束日期

2031年10月1日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Gottfried von Keudell, MD PhD

责任方

Sponsor Investigator

主要研究者

Gottfried von Keudell, MD PhD

Sponsor Investigator

Beth Israel Deaconess Medical Center

入排标准

入选标准

•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

排除标准

•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.

研究组 & 干预措施

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.

干预措施: Venetoclax