CTRI/2009/091/000110Other2 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
Biogen Idec LtdBiogen Idec Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria:
- •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 2.
- •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
- •Acceptable hematologic status
- •Acceptable renal function
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 1.
- •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 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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