EUCTR2010-023205-35-LT进行中（未招募）不适用
Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly orUnfit Patients with Chronic B Lymphocytic Leukemia - Rituximab in Pretreated Elderly or Unfit B-CLL patients
Vilnius University Hospital Santariskiu Clinics0 个研究点开始时间: 2010年10月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. The diagnosis of CD20 positive chronic B lymphocytic leukemia (B-CLL) confirmed by biopsy or flow-cytometry.
- •2. Previously treated patients with stage Rai I-IV and progressive disease (according to IWCLL 2008 guidelines).
- •Active B-CLL is defined by at least one of the following:
- •At least one of the disease related symptoms:
- •1. Constitutional symptoms:
- •1.1. Weight loss > 10% within the previous 6 months;
- •1.2. Fatigue (e. g. WHO performance status = 2);
- •1.3. Fever =38C = 2 weeks without evidence of infection;
- •1.4. Night sweats for more than 1 month without evidence of infection.
- •2. Evidence of progressive marrow failure as manifested by development of, or worsening of, anemia and/or thrombocytopenia
- •3. Autoimmune hemolysis and / or thrombocytopenia poorly responsive to corticosteroid therapy.
- •4. Massive (i. e. = 6 cm bellow left costal margin) or progressive or symptomatic splenomegaly.
- •5. Massive lymphadenopathy or conglomerates (i. e., = 10 cm in largest diameter) or progressive or symptomatic lymphadenopathy.
- •6. Progressive lymphocytosis with an increase > 50% over a 2-month period or an anticipated doubling time of less than 6 months. In patients with initial blood lymphocyte counts of less than 30x109/L LDT should not be used as a single parameter to define atreatment indication.
- •Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy.
- •3. Either of the following:
- •3.1. 18 years of age or older with impaired performance status (CIRS>6) and /or
- •3.2. 65 years of age or older with any performance status.
- •4. Signed informed consent form.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Intolerance to exogenous protein or known severe reaction to the administration of Rituximab.
- •2. Active infection.
- •3. Cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to Study Day 1.
- •4. TBC or fungal infection within the past 6 months even if adequately controlled by treatment.
- •5. Severe organ deficiency preventing the participation in the study.
- •6. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.
- •7. Active peptic ulcer.
- •8. Inadequately controlled diabetes mellitus.
- •9. Suspected or confirmed B-CLL CNS disease.
- •10. Known to be HIV positive.
- •11. Difficult to control, uncooperative patients.
- •12. Allergic disorders in need of chronic glucocorticoid therapy.
- •13. Other oncological diseases requiring active treatment (except hormonal therapy).
- •14. Pregnancy and breastfeeding.
- •15. Patients of reproductive potential who are not using effective methods of contraception.
研究者
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