NCT06553352招募中2 期
An Open, Single-Arm Clinical Study of Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma (FL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- CR
研究概览
简要总结
To evaluate the efficacy and side effects of Zanubrutinib combined with Obinutuzumab (ZO) in the treatment of newly diagnosed follicular lymphoma.
详细描述
Zanubrutinib (Z) 160mg bid oral d1-21 Obinutuzumab (O) C1 1000mg d1,8,15 C2-C6 d1 IV, then every 8 weeks until full 20 infusions (2 years maintenance)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years old and gender-neutral;
- •Follicular lymphoma definitively diagnosed according to the REAL/WHO classification, stage II-IV requiring treatment according to the GELF code;
- •ECOG score 0-2;
- •Lymphoma efficacy evaluation criteria using Lugano 2014 Lymphoma must have at least one measurable or evaluable lesion: signed informed consent, subjects recruited based on inclusion and exclusion criteria, etc History taking and pre-treatment baseline examination and registration on case report form (CRF) ZO regimen of chemotherapy for 6 cycles, followed by zebrutinib monotherapy orally for 6 months, with observation of toxicities Follow-up assessment (including) Follow-up evaluation (including safety) <Blood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire> Follow-up evaluation (including safety) <Blood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire, once every three months>
- •Zerbutinib maintenance treatment for 12 months for PR and above
- •Second-line treatment for the rest of the patients (recommended by NCCN guidelines) NCCN guideline recommendation) Assessment of efficacy i.e. PET/CT with evaluable lesions; CT or MR evaluation of intranodal lesions with a long diameter >1.5cm, short diameter >1.0cm or extranodal lesions with a long diameter >1.0cm;
- •HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) Enrollment only if HBV-DNA test is negative;
- •Normal major organ function: liver function serum bilirubin ≤ 2.0 × ULN , serum ALT and AST ≤ 2.5 × ULN, renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma);
- •Informed consent (patients must sign an informed consent form for all studies).
排除标准
- •Medically significant CNS lymphoma or molluscum contagiosum or large cell transformation;
- •HIV-positive patients and or HCV active infection (documented by HCV-RNA positive test);
- •Patients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia Patients should not have transfusion-dependent thrombocytopenia or bleeding disorders Patients should not have autoimmune disorders associated with the study drug;
- •Known bleeding disorders (e.g., vascular hemophilia or hemophilia) in combination with warfarin or other vitamin K antagonists require treatment with a potent cytochrome P450 (CYP) 3A inhibitor;
- •Patients with acute coronary syndrome within 6 months prior to study entry must not have had a stroke or intracranial hemorrhage within the past 6 months Prior Surgery: no major surgery within 28 days prior to enrollment or minor surgery within 7 days prior to enrollment; examples of minor surgery include dental procedures, venous access device insertion, skin biopsies, or joint aspirations; procedures may be major or minor at the discretion of the treating physician;
- •Severe COPD with combined hypoxemia;
- •Active bacterial, fungal, and, or viral infections not controlled by systemic therapy;
- •In addition to cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer that does not require systemic therapy, or early breast cancer that requires surgery alone. Other malignant tumors within the last 2 years or concurrently;
- •Pregnancy and Lactation: Female patients must have a negative serum pregnancy test within 72 hours prior to initiation of regimen therapy and use effective contraception during regimen therapy and for at least 12 weeks after completion of the study.
研究组 & 干预措施
Zanubrutinib (Z) combined with Obinutuzumab (O)
Experimental
Zanubrutinib (Z) 160mg bid oral d1-21 Obinutuzumab (O) C1 1000mg d1,8,15 C2-C6 d1 IV, then every 8 weeks until full 20 infusions (1 years maintenance)
干预措施: Zanubrutinib combined with Obinutuzumab (Drug)
结局指标
主要结局
CR
时间窗: up to 1 year
Complete remission rate
次要结局
未报告次要终点
研究者
Bing, Xu
Principal Investigator
The First Affiliated Hospital of Xiamen University
研究点 (1)
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