EUCTR2006-002987-24-GB进行中（未招募）1 期
A Randomized, Open-Label, Multicenter, Phase 2/3 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia - Lumiliximab in combination with FCR in the treatment of relapsed C
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
- •? Signed, written Ethics Committee (EC)-approved informed consent form.
- •? Diagnosed relapsed CD23+ and CD20+ B-cell CLL as defined by National Cancer Institute-Working Group (NCI-WG) Guidelines.
- •? Subjects who have received at least 1, but no more than 2, prior single agent or combination treatments for CLL.
- •? Rai Stage III or IV (Binet Stage C), or Rai Stage I or II (Binet Stage A or B) if determined to have disease progression as evidenced by rapid doubling of peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms (Staging Criteria – Modified Rai).
- •? World Health Organization (WHO) Performance Status < or = 2.
- •? Age > or = 18 years.
- •? Male and female subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.
- •? Acceptable liver function:
- •- Bilirubin < or = 2.0 mg/dL (34.2 µmol/L).
- •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ? Acceptable hematologic status:
- •- Platelet count >or = 50 x 10exp9/L should be unsupported by transfusion.
- •- Absolute neutrophil count (ANC) > or = 1 x 109/L.
- •? Acceptable renal function:
- •- Creatinine clearance calculated according to the formula of Cockroft and Gault >50 mL/min.
- •- Serum creatinine < or =1.5 times upper limit of normal.
- •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
- •? Subjects who are refractory to the following combination therapies: purine analogue+rituximab, purine analogue+cyclophosphamide, or purine analogue+cyclophosphamide and rituximab. Refractory is defined as not achieving at least a PR for a minimum duration of 6 months as determined by treating physician. Purine analogues include fludarabine, pentastatin, and cladribine.
- •? Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day.
- •? Previous exposure to lumiliximab or other anti-CD23 antibodies.
- •? Prior autologous or allogeneic bone marrow transplant (BMT) or hematopoetic stem cell transplant.
- •? Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Although testing for hepatitis B or hepatitis C is not mandatory, this should be considered for all subjects at high risk of hepatitis B or hepatitis C infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B or hepatitis C exposure are excluded unless the serological findings are clearly due to vaccination.
- •? Uncontrolled diabetes mellitus.
- •? Uncontrolled hypertension.
- •? Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter’s Syndrome, or prolymphocyte leukemia [PLL]).
- •? Secondary malignancy requiring active treatment (except hormonal therapy).
- •? Any medical condition that would require long-term use (>1 month) of systemic corticosteroids during study treatment. However, steroid use ? Any serious nonmalignant disease or laboratory abnormality, which in the opinion of the Investigator and/or Sponsor would compromise protocol objectives.
- •? Active uncontrolled bacterial, viral, or fungal infections.
- •? New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Study Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) within 30 days prior to Study Day 1.
- •? Seizure disorders requiring anticonvulsant therapy.
- •? Severe chronic obstructive pulmonary disease with hypoxemia.
- •? Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.
- •? Clinically active autoimmune disease.
- •? History of fludarabine-induced autoimmune cytopenia as judged by the Investigator or Coombs-positive haemolytic anemia.
- •? Pregnant or currently breastfeeding.
研究者
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