EUCTR2017-001552-54-GB进行中（未招募）1 期
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined with Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/Refractory Follicular Lymphoma
BeiGene Ltd.0 个研究点目标入组 210 人开始时间: 2017年10月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each patient eligible to participate in this study must meet all of the following criteria:
- •-= 18 years of age at the time of informed consent
- •-Histologically confirmed diagnosis of B-cell follicular lymphoma (grade 1, 2 or 3a) based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue
- •-= 2 prior systemic treatments for follicular lymphoma
- •-Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy including
- •a.Rituximab, cyclophosphamide, doxorubicin, vincristine, and
- •prednisolone
- •b.Rituximab, cyclophosphamide, vincristine, and prednisolone
- •c.Bendamustine plus rituximab
- •-Disease progression after completion of most recent therapy or refractory disease, defined as failure to achieve CR or PR to most recent therapy, and most recent therapy was an appropriate second-line (or later) systemic therapy for follicular lymphoma
- •-Presence of measurable disease, defined as = 1 nodal lesion that is > 2 cm in longest diameter, or = 1 extranodal lesion that is > 1 cm in longest diameter
- •-Availability of archival tissue confirming diagnosis of B-cell follicular lymphoma (or if archival tissue is not available, a copy of the pathology report confirming diagnosis of B-cell follicular lymphoma is required)
- •-Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •-Life expectancy = 6 months
- •-Adequate organ function defined as:
- •a. Absolute neutrophil count (ANC) = 1000/mm3 except when neutropenia is assessed by the investigator to be directly due to active lymphoma, in which case ANC must be = 750/mm3.
- •b. Platelet > 50,000/mm3 (without growth factor support or transfusion within 7 days)
- •c. Creatinine clearance = 30 mL/min (as estimated by the Cockcroft-Gault or MDRD equation or as measured by nuclear medicine scan or 24-hour urine collection)
- •d. Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase, and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase = 3.0 × upper limit of normal (ULN)
- •e. Serum total bilirubin < 2.0 × ULN (unless documented Gilbert’s syndrome)
- •Female patients of childbearing potential must practice highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for = 90 days after the last dose of zanubrutinib, or 18 months after the last dose of obinutuzumab, whichever is longer. Highly effective contraceptive methods include the following:
- •a. Combined (estrogen and progestogen containing) hormonal contraception associated with the inhibition of ovulation
- •i. Oral, intravaginal or transdermal
- •b. Progestogen-only hormonal contraception associated with the inhibition of ovulation
- •i. Oral, injectable, implantable
- •c. An intrauterine device
- •d. Intrauterine hormone-releasing system
- •e. Bilateral tubal occlusion
- •f. Vasectomized partner
- •g. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment, starting the day prior to first dose of study drug, for the duration of the study, and for = 90 days after the last dose of zanubrutinib, or 18 months after the last dose of obinutuzumab, whichever is longer). Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients’ usual and preferred lifestyle. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration
排除标准
- •Each patient eligible to participate in this study must NOT meet any of the following exclusion criteria:
- •1. Known central nervous system involvement by leukemia or lymphoma
- •2. Evidence of transformation from follicular lymphoma to DLBCL or other aggressive histology (such as large cells seen on biopsy or high PET avidity in a single node seen on PET scan)
- •3. Allogeneic hematopoietic stem cell transplantation within 12 months of study enrollment
- •4. Prior exposure to a BTK inhibitor
- •5. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
- •6. Clinically significant cardiovascular disease including the following:
- •a. Myocardial infarction within 6 months before screening
- •b. Unstable angina within 3 months before screening
- •c. New York Heart Association class III or IV congestive heart failure (See Appendix 4)
- •d. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- •e. QTcF > 480 milliseconds based on Fridericia’s formula
- •f. History of Mobitz II second-degree or third degree heart block without a permanent pacemaker in place
- •g. Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg at screening
- •7. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- •8. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
- •9. Severe or debilitating pulmonary disease
- •10. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
- •11. Active fungal, bacterial and/or viral infection requiring systemic therapy
- •12. Underlying medical conditions that, in the investigator’s opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results
- •13. Known infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:
- •a. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (< 20 IU/mL), and if they are willing to undergo monthly monitoring for HBV reactivation.
- •b. Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (<15 IU/mL).
- •14. Major surgery within 4 weeks of the first dose of study drug
- •15. Pregnant or lactating women
- •16. Vaccination with a live vaccine within 35 days prior to the first dose of study drug
- •17. Ongoing alcohol or drug addiction
- •18. Hypersensitivity to zanubrutinib or obinutuzumab or any of the other ingredients of the study drugs
- •19. Requires ongoing treatment with a strong CYP3A inhibitor or inducer
- •20. Concurrent participation in another therapeutic clinical trial.
- •21.Requires ongoing need for corticosteroid treatment. NOTE: Systemic corticosteroids must be fully taper
研究者
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