2023-503755-10-00
招募中
3 期
Phase 3, interventional, multicentre, open label, randomized study comparing rituximab plus zanubrutinib to rituximab monotherapy in previously untreated, symptomatic splenic marginal zone lymphoma (RITZ)
Association International Extranodal Lymphoma Study Group42 个研究点 分布在 7 个国家目标入组 90 人开始时间: 2024年4月24日最近更新:
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Association International Extranodal Lymphoma Study Group
- 入组人数
- 90
- 试验地点
- 42
- 主要终点
- Investigator-assessed PFS rate at 3 years according to the Lugano 2014 criteria
概览
简要总结
The primary objective of the trial is to evaluate the efficacy of the addition of zanubrutinib to rituximab versus rituximab monotherapy in subjects with previously untreated SMZL in terms of Progression free Survival (PFS).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign a written informed consent in accordance with ICH/GCP regulations before registration and prior to any trial-specific procedures.
- •Absolute neutrophil count (ANC) ≥ 1.0 x 109/L, platelet count ≥ 50 x 109/L, Hb > 7.5 g/dl. Values below such thresholds are allowed if attributable to the underlying lymphoma. Transfusions are allowed if clinically indicated during screening.
- •Adequate hepatic and renal function and coagulation parameters
- •Patient able and willing to swallow trial drugs as whole tablet/capsule.
- •Female subjects who are of non-reproductive potential and female subjects of childbearing potential with a negative serum pregnancy test upon study entry.
- •Male and female subjects who agree to use highly effective methods of birth control during the period of therapy and for 12 months after the last dose of rituximab and 30 days after the last dose of zanubrutinib.
- •Confirmed diagnosis of SMZL, including Matutes immunophenotype score <
- •Evaluation of the following features is desirable: absence of CD103, expression by flow cytometry, absence of Cyclin D1, BCL6, and CD10 expression by immunohistochemistry, and absence of the MYD88 L265P mutation. Patients with prominent splenomegaly and involvement of the splenic hilar and/or extra hilar lymph nodes are eligible.
- •Previously untreated disease. Patients with prior hepatitis C virus (HCV) infection who underwent HCV eradication and have persistent SMZL after 3 months post-eradication can be included.
- •Treatment needs according to the ESMO guideline criteria.
排除标准
- •Previous splenectomy
- •History of confirmed progressive multifocal leukoencephalopathy
- •Concomitant diseases that require anticoagulant therapy with warfarin or phenprocoumon or other vitamin K antagonists and patients treated with dual anti-platelet therapy. Patients being treated with factor Xa inhibitors (eg, rivaroxaban, apixaban, edoxaban), direct thrombin inhibitors (e. dabigatran) low molecular weight heparin (LMWH), or single anti-platelet agents (eg. aspirin, clopidogrel) can be included but must be properly informed about the potential risk of bleeding
- •Malabsorption syndrome or other condition that precludes the enteral route of administration
- •Other sever acute or chronic medical or psychiatric condition or laboratory abnormalities which may increase the risk associates with trial participation and/or would make the patient inappropriate for enrolment into this trial.
- •Pregnancy or breastfeeding.
- •Concurrent participation in another therapeutic clinical trial.
- •Any uncontrolled active systemic infection requiring intravenous antimicrobial treatment, known human immunodeficiency virus (HIV) infection, active COronaVIrus Disease 19 (COVID-19) infection, presence of viral hepatitis B surface antigen (HBsAg) or viral hepatitis B core antibody (HBcAb), Presence of HCV antibody
- •Active, uncontrolled autoimmune phenomenon
- •Concomitant treatment with strong CYP3A inducers or inhibitors.
结局指标
主要结局
Investigator-assessed PFS rate at 3 years according to the Lugano 2014 criteria
Investigator-assessed PFS rate at 3 years according to the Lugano 2014 criteria
次要结局
- Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Lugano 2014 criteria.
- Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Lugano 2014 criteria
- Investigator-assessed complete remission rates achieved at 12 and 24 months of treatment, assessed according to the Matutes criteria
- Investigator-assessed best response achieved at any time during the treatment period (24 months) assessed according to the Matutes criteria
- Investigator-assessed Time to next anti-lymphoma treatment (TTNT) according to the Lugano 2014 criteria
- Investigator-assessed duration of response according to the Lugano 2014 criteria
- Overall Survival according to the Lugano 2014 criteria
- Analysis of type and severity of adverse events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
研究者
IELSG Operation Office
Scientific
Association International Extranodal Lymphoma Study Group
研究点 (42)
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