EUCTR2009-012476-28-IT进行中（未招募）1 期
An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO5072759 + chlorambucil (GClb), rituximab + chlorambucil (RClb)or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities. - CLL11
F.Hoffmann-La Roche0 个研究点目标入组 781 人开始时间: 2010年1月13日最近更新:
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
- 781
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. Have documented CD20+ B-CLL according to NCI criteria 2. Previously untreated CLL requiring treatment according to the NCI criteria (Hallek,M; Blood 2008) 3. Total CIRS score >6 (Appendix 3) or creatinine clearance <70 ml/min or both (Appendix 4) 4. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L) and platelets (Plt) ≥ 75 x 109/L unless cytopenia is caused by the underlying disease, i.e. no evidence of additional bone marrow dysfunction (e.g. myelodysplastic syndrome [MDS], hypoplastic bone marrow) 5. Age 18 years or older 6. Life expectancy >6 months 7. Able and willing to provide written informed consent and to comply with the study protocol procedures.
- •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 who have received previous CLL therapy 2. Transformation of CLL to aggressive NHL (Richter s transformation) 3. One or more individual organ / system impairment score of 4 as assessed by the CIRS definition 4. Inadequate renal function: Creatinine clearance < 30 ml/min 5. Inadequate liver function: NCICTC Grade 3 liver function tests (AST, ALT >5 x ULN for >2 weeks; Bilirubin >3 x ULN) unless due to underlying disease. 6. Patients with manifest auto-immune haemolytic anemia (AIHA). However, Coombs positive with no clinical signs of AIHA are eligible. 7. History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of malignancy that has been treated but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrolment. 8. Patients with active bacterial, viral, or fungal infection requiring systemic treatment. 9. Patients with known infection with Human immunodeficiency virus (HIV) or Human T Cell Leukemia Virus 1 (HTLV-1). 10. Positive hepatitis serology (see also protocol Section 5.9.2): Hepatitis B (HBV): Patients with positive serology for Hepatitis B defined as positivity for Hepatitis B surface antigen (HBsAg) or anti Hepatitis B core antibody (anti-HBc). Patients positive for anti-HBc may be included if Hepatitis B viral DNA is not detectable. Hepatitis C (HCV): Patients with positive Hepatitis C serology 11. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products. 12. Hypersensitivity to Clb or to any of the excipients 13. Women who are pregnant or lactating 14. Fertile men or women of childbearing potential unless: (1) surgically sterile or ≥ 2 years after the onset of menopause (2) willing to use a highly effective of contraceptive method (Pearl Index <1) such as oral contraceptives, intrauterine device, sexual abstinence or barrier method of contraception in conjunction with spermicidal jelly during study treatment and in female patients for 12 months after end of antibody treatment and male patients for 6 months after end of chlorambucil treatment.
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