EUCTR2004-002859-13-SK进行中（未招募）1 期
A randomized phase III trial comparing two schedules of rituximab maintenance in rituximab-responding patients with untreated, chemotherapy resistant or relapsed follicular lymphoma.
SIAK0 个研究点目标入组 270 人开始时间: 2007年1月23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
- 270
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. Histologically confirmed follicular lymphoma grade 1, 2, 3a or 3b according to WHO classification
- •2. CD20 expression on immunohistochemistry
- •3. Any of the following disease status:
- •- untreated
- •- relapsed/progressed
- •- chemotherapy resistant disease
- •- stable disease (last administration of the last systemic treatment must be at least 12 weeks before patients registration)
- •4. Patients previously treated with rituximab or radiolabelled anti CD-20 therapy (either alone or in combiation with cytostatics) must have responded to the anti CD-20 containing regimen (CR or PR). At least 12 months must have elapsed from the last anti CD-20 therapy administration.
- •5. Patients must have at least one two-dimensionally measurable lesion with greatest transverse diameter = 11 mm in CT scan (MRI is allowed only if CT scan cannot be performed).
- •6. Patients must give written informed consent before registration
- •7. Patients must have the capability to understant information given by the investigator on the trial.
- •8. Age must be = 18 years.
- •9. Performance status must be = 2 on the WHO performance status
- •10. Adequate cardiac function (EF = 50%) as assessed by echocardioigraphy or MUGA scan.
- •11. Patient compliance and geographic proximity that allow proper staging and follow-up.
- •12. Women not breast feeding, are using effective contraception if sexually active, are not pregnant and agree not to become pregnant during participatioin in the trial and during the 12 months thereafter. A negative pregnancy test is required for women with childbearing potential.
- •13. Patient has recieved 4 doses of rituximab prior to randomization
- •14. At least 11 weeks have elapsed from start of rituximab induction therapy prior to randomization.
- •15. All lesions reported in the On-Study Form have been re-evaluated at restaging prior to randomization procedures.
- •16. Patient must have reached a PR or CR at restaging prior to randomization
- •Are the trial subjects under 18?
- •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. Patients with prior or concomitant malignancies, except non-melanomatous skin cancer or adequately treated in situ cervical cancer.
- •2. Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningiosis).
- •3. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. acute or ongoing infection, HIV-infection, uncontrolled diabetes mellitus, active autoimmune disease).
- •4. Transformation to high-grade lymphoma (secondary to low-grade Follicular Lymphoma).
- •5. Patients regurarly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to =20 mg /day prednisone for indications other than lymphoma or lymphoma-related symptoms.
- •6. Systemic tumor therapy in the last 30 days.
- •7. Treatment in a clinical trial within 30 days prior to trial entry.
- •8. Serious underlying medical conditioins, which could impair the ability of the patient to participate in the trial
研究者
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