EUCTR2010-021253-39-DK进行中（未招募）1 期
Rituximab plus lenalidomide or rituximab monotherapy for untreated patients with follicular lymphoma in need of therapy. A randomized, open-label, multicentre phase II trial.
Swiss Group for Clinical Cancer Research SAKK0 个研究点目标入组 152 人开始时间: 2011年7月25日最近更新:
适应症
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
- 152
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
- •-Histologically confirmed FL CD20+; grade 1, 2, 3a; stage III+IV; stage II not suitable for radiotherapy
- •-Patients in need of systemic therapy: (at least one of these indications must be fulfilled)
- •symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations
- •bulky disease = 6 cm in long diameter
- •clinically significant progression over at least 6 months of any tumor lesion
- •anemia (Hb < 100 g/L) or thrombocytopenia (Platelets < 100 x 109/L) due to lymphoma
- •clinically significant progressive decrease in Hb or platelet count due to lymphoma
- •B-symptoms ,weight loss > 10 % in 6 months, drenching night sweats or fever > 38°C not due to infection
- •-Patients must have at least one two-dimensionally measurable lesion with longest transverse diameter > 10 mm
- •-Paraffin embedded tumor tissue is available for sending for pathology review
- •-Age > 18 years
- •-WHO performance status 0-2
- •-For patients with history of cardiac disease or older than 70 years: adequate cardiac function must be confirmed by EF = 50%
- •-Adequate hematological values unless due to marrow infiltration by FL: (Neutrophils = 1.5 x 109/l, Platelets = 100 x 109/l)
- •-Adequate hepatic function: Bilirubin = 1.5 x ULN (unless due to Gilbert’s syndrome), ALT/AP = 2.5 x ULN
- •-Adequate renal function (calculated creatinine clearance = 30 ml/min, according to the formula of Cockroft-Gault)
- •-Patient must give written informed consent before randomization
- •-Patient compliance and geographic proximity allow proper staging and follow-up
- •-Women with Childbearing potential
- •are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter
- •are using effective contraception since 30 days at least
- •have a negative pregnancy test within 4 days before randomization
- •-Men agree not to father a child, not to donate semen and to use condoms during trial treatment and 12 months thereafter
- •-Patients (male and female) agree to follow the special pregnancy prevention requirements for Revlimid® (lenalidomide)
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-Previous systemic therapy for follicular lymphoma
- •-Radiotherapy within the last 3 months
- •-Known CNS involvement
- •-Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes)
- •-Previous malignancy within 3 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- •-Psychiatric disorder precluding understanding information of trial related topics, giving informed consent, or interfering with compliance for oral drug intake
- •-Known hypersensitivity to trial drug(s) or hypersensitivity to any other component of the trial drugs
- •-Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information
- •-Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry
- •-Known HIV+ infection or HCV infection
- •-Patients with any serological evidence of current or past hepatitis B, unless the serological findings are clearly due to vaccination
- •-Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to Prednisone = 15 mg/day for indications other than lymphoma or lymphoma-related symptoms
- •-Pregnant or lactating females
研究者
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