EUCTR2012-003230-17-DK进行中（未招募）1 期
A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN’S LYMPHOMA GRADES 1, 2 OR 3A
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
- 900
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. Age = 18 and = 80 years at time of randomization
- •2. Histologically confirmed, previously untreated CD20+ DLBCL or CD20+ follicular NHL Grade 1, 2 or 3a, according to the WHO classification system
- •3. An IPI score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion = 7.5 cm, or FLIPI (low, low-intermediate, high-intermediate, high)
- •4. At least one bi-dimensionally measurable lesion defined as = 1.5 cm in its largest dimension on CT scan
- •5. Eastern Cooperative Oncology Group (ECOG) performance status = 3.
- •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 460
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Transformed lymphoma or FL IIIB
- •2. Primary CNS lymphoma, blastic variant of mantle-cell lymphoma, histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL or primary DLBCL of the testis
- •3. History of other malignancy that could affect compliance with the protocol or interpretation of results. This includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for = 5 years prior to enrolment. Note: Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible for the study.
- •4.Prior therapy for DLBCL or follicular NHL, with the exception of nodal biopsy or local irradiation
- •5.Prior treatment with cytotoxic drugs (with the exclusion of methotrexate for CNS prophylaxis in DLBCL) or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody
- •6.Prior use of any monoclonal antibody within 3 months prior to randomization
研究者
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不适用
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