NCT00391066终止2 期
A Randomized, Open Label, Multicenter, Phase 2 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 627
- 试验地点
- 1
- 主要终点
- Complete Response (CR) rate
研究概览
简要总结
This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed, written EC-approved informed consent form.
- •Diagnosis of relapsed CD23+ and CD20+ B cell CLL as defined by 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).
- •WHO Performance Status less than or equal to
- •Age greater than or equal to 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 less than or equal to 2.0 mg/dL (26 µmol/L); AST and ALT less than or equal to 2 times upper limit of normal.
- •Acceptable hematologic status: platelet count greater than or equal to 50 x 10^9/L should be unsupported by transfusion; ANC greater than or equal to 1 x 10^9/L.
- •Acceptable renal function: creatinine clearance calculated according to the formula of Cockcroft and Gault >50 mL/min; serum creatinine less than or equal to 1.5 times upper limit of normal.
排除标准
- •Subjects who are refractory to the following combination therapies: purine analogue + R, purine analogue + C, or purine analogue + CR. 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, pentostatin 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 BMT or hematopoetic stem cell transplant.
- •Known infection with HIV, hepatitis B, or hepatitis C. Although testing for hepatitis B or hepatitis C is not mandatory, this should be considered for all subjects considered 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 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 less than or equal to 1 month is permissible during the study.
- •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 ECG within 30 days prior to Study Day
- •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
- •Clinically active autoimmune disease.
- •History of fludarabine-induced autoimmune cytopenia (as judged by the Investigator) or Coombs-positive haemolytic anemia.
- •Pregnant or currently breastfeeding.
研究组 & 干预措施
1
Active Comparator
FCR
F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks
C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks
R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks
干预措施: FCR (Drug)
2
Experimental
FCR + Lumiliximab (L)
L (Lumiliximab): Day 2 50 mg/m2, Day 4 450 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks.
F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks
C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks
R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks
干预措施: FCR + Lumiliximab (Drug)
结局指标
主要结局
Complete Response (CR) rate
时间窗: Every 3 months until all patients have reached at least week 33
次要结局
- Response variables(Every 3 months until all patients have reached at least week 33)
- Time to event variables (progression free survival, duration of response, time to next therapy, time to progression and overall survival)(Every 3 months until all patients have reached at least week 33)
研究者
研究点 (1)
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