EUCTR2007-000172-16-GB进行中（未招募）1 期
An open-label study to characterize the safety and response rate of MabThera (Rituximab) plus chlorambucil in previously untreated patients with CD20-positive B-cell chronic lymphocytic leukemia. - not applicable
F. Hoffmann-La Roche Limited0 个研究点目标入组 100 人开始时间: 2007年6月3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
- 100
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
入选标准
- •1. Patients with CD20-positive B-cell CLL (NCI criteria) who are previously untreated
- •2. Patients with progressive Binet stage B, or C requiring therapy according to NCI criteria
- •3. Age = 18 years
- •4. Signed written informed consent
- •5. Life expectancy > 6 months
- •6. Eastern Co-operative Oncology Group (ECOG) performance status 7. Absolute Neutrophil Count (ANC) = 1x109/L
- •8. Platelet count >/= 50x109/L, unless due to involvement of bone marrow by CLL
- •9. Total bilirubin 10. Alkaline phosphatase and transaminases 11. A negative serum pregnancy test up to one week prior to the first cycle of treatment must be available both for pre-menopausal women and for women who are
- •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. Patients with other malignancy within the last 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ of the breast treated with lumpectomy alone with curative intent.
- •2. Patients with known concomitant haematological malignancy; e.g. myelodysplastic syndromes.
- •3. Patients with reproductive potential not willing to use effective method of contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- •4. Patients who have received previous treatment for CLL
- •5. Patients with active bacterial, viral, or fungal infection requiring systemic therapy
- •6. Patients with a history of severe cardiac disease; e.g. New York Heart Association (NYHA) Functional Class III or IV heart failure [Appendix 3], myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina
- •7. Patients with significant autoimmune cytopenia as assessed by the physician (Coombs positive patients without clinical signs of autoimmune haemolytic anaemia are eligible for study entry)
- •8. Patients with severe chronic obstructive pulmonary disease (COPD) with hypoxemia
- •9. Patients with uncontrolled diabetes mellitus (defined as HbA1c >/= 10%)
- •10. Patients with uncontrolled hypertension (normally defined as blood pressure repeatedly >/= 140/90mmHg, but investigator discretion to be used)
- •11. Patients with transformation to aggressive B-cell malignancy (e.g. large B-cell lymphoma, Richter’s syndrome or polymorphocytic leukaemia (PLL))
- •12. Patients who have received any investigational treatment, or participating in another clinical trial, within 30 days of study start
- •13. Patients with known Human Immunodeficiency Virus (HIV) infection, or active Hepatitis B (HBV) or Hepatitis C (HCV) infection.
- •14. Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
- •15. Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
- •16. Hypersensitivity to chlorambucil or to any of the excipients
研究者
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