EUCTR2006-001433-17-NL进行中（未招募）不适用
A double-blind, randomized, two-dose-arm, parallel group, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with Follicular Lymphoma who are refractory to rituximab in combination with chemotherapy - HuMax-CD20 in FL patients refractory to rituximab
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
- 入组人数
- 162
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
- •1)Patient with follicular lymphoma grade 1 – 2 (defined according to WHO guidelines)
- •2)Refractory to rituximab in combination with chemotherapy (e.g. R-F, R-CVP, R-CHOP, R-FM, R-FCM), or to rituximab given as maintenance treatment, is defined as:
- •a.failure to achieve at least PR to rituximab in combination with chemotherapy;
- •b.disease progression while on rituximab (either in combination with chemotherapy or during rituximab maintenance treatment);
- •c.disease progression in responders within 6 months of the last dose of rituximab (either in combination with chemotherapy or after rituximab maintenance treatment schedule)
- •3)Tumor verified to be CD20+ positive from excisional lymph node biopsy . The excisional lymph node biopsy has to be redone if: no tissue is available for central review or if there is clinical suspicion that the follicular lymphoma has transformed to aggressive lymphoma/higher malignancy grade
- •4)CT scan in screening phase (based on local evaluation) showing:
- •a.2 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or
- •b.1 clearly demarcated lesion with a largest diameter = 2,0 cm
- •5)ECOG Performance Status of 0, 1, or 2
- •6)Age = 18 years
- •7)Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Previous autologous stem cell transplantation, within 6 months prior to Visit 1
- •2)Previous allogeneic stem cell transplantation
- •3)More than 1 previous radio immunotherapy regimen
- •4)Received radio immunotherapy within 3 months prior to Visit 1
- •5)Received any of the following treatments within 4 weeks prior to Visit 1:
- •Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues)
- •Glucocorticoid unless given in doses equivalent to = 10 mg of prednisolone /day
- •6)Received monoclonal antibodies, other than rituximab, within 3 months prior to Visit 1
- •7)Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
- •8)Clinical suspicion that the follicular lymphoma transformed to aggressive lymphoma (e.g. B-symptoms, fast growing tumor or increasing LDH level) unless a new biopsy, just before study entry, confirms follicular lymphoma
- •9)Known or suspected CNS involvement of FL
- •10)Past or current malignancy, except for:
- •Follicular Lymphoma
- •Cervical carcinoma Stage 1B or less
- •Non-invasive basal cell and squamous cell skin carcinoma
- •Malignant melanoma with a complete response of a duration of > 10 years
- •Other cancer diagnoses with a complete response of a duration of > 5 years
- •11)Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
- •12)Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
- •13)Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
- •14)History of significant cerebrovascular disease
- •15)Known or suspected HIV positive
- •16)Positive serology for hepatitis B
- •17)Screening laboratory values:
- •CD20 positive circulating lymphoma cells >10 x 10E9/L
- •platelets < 50 x 10E9/L
- •neutrophils < 1.0 x 10E9/L
- •creatinine > 1.5 times upper normal limit (unless normal creatinine clearance)
- •total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of FL)
- •ALT > 2.5 times upper normal limit (unless due to liver involvement of FL)
- •alkaline phosphatase > 2.5 times upper normal limit (unless due to liver involvement of FL)
- •18)Known or suspected hypersensitivity to components of investigational product
- •19)Patients with pleural effusion or ascites of significant degree, defined as detectable by physical examination
- •20)Life expectancy less than 6 months
- •21)Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 1
- •22)Current participation in any other interventional clinical study
- •23)Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- •24)Breast feeding women or women with a positive pregnancy test at Visit 1
- •25)Women of childbearing potential not willing to use adequate contraception during study and one year after last dose of HuMax-CD20. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double b
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