NCT07261163
尚未招募
2 期
Obinutuzumab, Zanubrutinib, and Lenalidomide as First-Line Therapy for Mantle Cell Lymphoma: A Prospective, Single-Arm, Open-Label, Multicenter Study
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2025年12月20日最近更新:
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- complete response rate (CR)
概览
简要总结
This is a prospective, open-label, single-arm clinical trial evaluating a treatment strategy for previously untreated Mantle Cell Lymphoma (MCL). The study will enroll patients who have not received prior systemic therapy for MCL. All patients will receive the ZGR induction regimen. Risk-adapted maintenance therapy will be applied: non-high-risk patients will receive lenalidomide and zanubrutinib maintenance for 1 and 2 years, respectively; high-risk patients will undergo CAR-T cell therapy followed by the same maintenance regimen. The primary objective is to assess the feasibility and preliminary efficacy of this treatment approach in the first-line setting of MCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years inclusive, both genders are eligible.
- •Histologically or cytologically confirmed diagnosis of Mantle Cell Lymphoma (MCL), with at least one measurable lesion according to Lugano criteria.
- •No prior systemic therapy for MCL.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Adequate organ function, defined as:
- •Hematologic function (without red blood cell or platelet transfusion, growth factor support, or medication correction within 14 days prior to enrollment):Absolute neutrophil count (ANC) ≥ 1 × 10⁹/L;Platelet count (PLT) ≥ 75 × 10⁹/L;
- •Biochemical tests must meet the following criteria::
- •Total bilirubin ≤ 2.0 × upper limit of normal (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × ULN;Creatinine clearance ≥ 30 mL/min, calculated by the Cockcroft-Gault formula;
- •Cardiac function:Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram.
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study treatment, and must agree to use a highly effective method of contraception (e.g., intrauterine device, hormonal contraception, or condom use) during the study and for 6 months after the last dose of study drug. Male subjects whose partners are of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 6 months after the last dose of study drug.
排除标准
- •Known central nervous system (CNS) involvement, including brain or meningeal lymphoma.
- •Congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac dysfunction.
- •History of other primary malignancies within the past 3 years, except for non-melanoma skin cancer, localized prostate cancer considered cured, cervical in situ carcinoma, or squamous intraepithelial lesion detected by PAP smear.
- •Prior treatment with investigational drugs.
- •Active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to first administration of study drug.
- •Use of immunosuppressive agents within 7 days prior to first administration of study drug, except for intranasal or inhaled corticosteroids, or systemic corticosteroids at physiologic doses (i.e., ≤ 20 mg/day prednisone or equivalent).
- •History of hypersensitivity, allergic reactions, or adverse drug reactions:Severe hypersensitivity reaction to monoclonal antibodies;Allergy or intolerance to infusions;History of severe allergy to study drugs or premedication agents.
- •Physical or laboratory findings:Congenital or acquired immunodeficiency, such as active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive HCV antibody and HCV-RNA above lower limit of detection), or co-infection with both HBV and HCV; Pregnant or breastfeeding women; subjects of childbearing potential unwilling or unable to use effective contraception; Known history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).
- •Any condition that, in the investigator's judgment, may impair subject safety or ability to comply with the study protocol.
- •Other conditions deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
ZGR
Experimental
干预措施: Zanubrutinib (Drug)
ZGR
Experimental
干预措施: Obinutuzumab (Drug)
ZGR
Experimental
干预措施: Lenalidomide (Drug)
ZGR
Experimental
干预措施: CAR-T Cell Therapy (Other)
结局指标
主要结局
complete response rate (CR)
时间窗: up to the end of 6 cycles of treatment (each cycle is 28 days)
To assess the complete response rate (CR) at the end of Induction therapy \[Time Frame: up to the end of induction treatment
次要结局
- Overall Response Rate (ORR)(up to the end of 6 cycles of treatment (each cycle is 28 days))
- The safety(Time Frame: up to 5 years)
- Duration of Response (DoR)([Time Frame: up to 5 years])
- Progression-free survival (PFS)([Time Frame: up to 5 years])
- Overall survival([Time Frame: up to 10 years])
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström MacroglobulinemiaNCT07259122Institute of Hematology & Blood Diseases Hospital, China43
招募中
不适用
Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell LymphomaNCT07257510Peking University Third Hospital34
撤回
2 期
Phase 1b/2a Study to Evaluate Alnuctamab in Combination with Mezigdomide in Relapsed and/or Refractory Multiple Myeloma.2023-504367-16-00Celgene International II S.a.r.l.14
已完成
2 期
A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)2022-502227-22-00Kezar Life Sciences Inc.82
尚未招募
3 期
Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer2024-513540-29-00Alliance Foundation Trials LLC303