EUCTR2017-001552-54-IT进行中（未招募）1 期
An International, Phase 2, Open-Label, Randomized Study of BGB-3111Combined with Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/Refractory Follicular Lymphoma - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •-= 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 (such as rituximab, cyclophosphamide,
- •doxorubicin, and prednisolone; rituximab, cyclophosphamide, vincristine,
- •and prednisolone; or bendamustine plus rituximab)
- •-Disease progression within 12 months 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
- •-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,
- •-Life expectancy = 6 months
- •-Adequate organ function defined as:
- •a. Absolute neutrophil count (ANC) > 750/mm3 (without growth factor
- •support within 7 days)
- •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
- •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
- 另有 9 项未显示
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 5 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
- •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 msecs 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
- •mm Hg and diastolic blood pressure > 105 mm Hg 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
- 另有 6 项未显示
研究者
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