EUCTR2013-004635-69-NL进行中（未招募）1 期
A phase II study of obinutuzumab monotherapy in rituximab-refractory follicular lymphoma
VU University Medical Center0 个研究点目标入组 25 人开始时间: 2014年3月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
入选标准
- •Biopsy-proven rituximab refractory follicular lymphoma (defined as disease progression while on rituximab maintenance therapy). Patients are required to have received a minimum of 2 infusions of rituximab maintenance therapy and/or be on a maintenance schedule for a minimum of 3 months (measured from the time of first maintenance infusion). Disease progression must have occurred before the last maintenance infusion.
- •No clinical or pathological evidence of transformation to high-grade or diffuse large B-cell lymphoma (e.g. B symptoms, fast-growing tumour, or increasing lactate dehydrogenase level)
- •Patients must have radiographically documented measurable disease, defined as 2 or more clearly demarcated lesions with a largest diameter of at least 1.5 cm or 1 clearly demarcated lesion with a largest diameter of at least 2.0 cm by computed tomography scan. All radiology studies must be performed within 14 days prior to registration.
- •Adult patients, >=18 years of age
- •Clinical indication for treatment as determined by the treating physician”
- •ECOG performance status of 0, 1 or 2.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Before patient registration, written informed consent must be given according to GCP, and national regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Known central nervous system involvement
- •Concurrent use of other anti-cancer agents
- •All other lymphoma treatment (except rituximab maintenance therapy) during the last 6 months.
- •Concurrent use of glucocorticoids (>10mg/day prednisolone or equivalent), or glucocorticoids (>10mg/day prednisolone or equivalent) within 4 weeks of first infusion
- •Prior use of any investigational monoclonal antibody within 6 months of study start
- •Prior use of any anti-cancer vaccine
- •Previous allogeneic stem cell transplantation at any time or previous autologous stem cell transplantation within 6 months of first infusion
- •More than 1 previous radioimmunotherapy
- •Radioimmunotherapy within 3 months of first infusion
- •Other active malignancy or history of other active malignancy. However patients who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
- •Intolerance of exogenous protein administration
- •Pregnant and breastfeeding women and those of childbearing potential who are not able or willing to use adequate and effective contraception.
- •Definition of adequate and effective contraception: use of two reliable forms of contraception.
- •For women, effective contraception is required to continue for = 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for = 3 months after the last dose of obinutuzumab.
- •Life expectancy < (less than) 6 months
- •Clinical significant cardiovascular disease, such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina)
- •Active infectious disease, requiring systemic treatment:
- •o Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B virus surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb] serology)
- •o Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
- •o Vaccination with a live vaccine within 28 days prior to the start of study drug (Cycle 1, Day 1)
- •o Known HIV or HTLV-1 infection
- •Any of the following abnormal laboratory values:
- •oCreatinine >1.5 times the upper limit of normal (unless creatinine clearance normal), or creatinine clearance <40 ml/min
- •oAspartate aminotransferase (AST) or alanine aminotransferase (ALT) ?>2.5 times the upper limit of normal
- •oTotal bilirubin >3 x ULN
- •oNeutrophil count <1.5 x 109/L (unless due to underlying disease, as established by extensive bone marrow involvement)
- •oHemoglobin <8 g/dL (unless due to underlying disease, as established by extensive bone marrow involvement)
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