NCT00151736终止2 期
A Randomized, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL)
Cephalon22 个研究点 分布在 5 个国家目标入组 88 人开始时间: 2004年9月最近更新:
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
- 入组人数
- 88
- 试验地点
- 22
- 主要终点
- Bone Marrow Biopsy or Aspiration
研究概览
简要总结
This is a Phase 2, multi-center, open label, randomized clinical study to evaluate the safety and efficiency of SDX-101 in combination with chlorambucil (CLB) and chlorambucil alone in Chronic Lymphocytic Leukaemia (CLL) patients. The study treatment period will be approximately 24-26 weeks with a follow-up period of approximately 8 weeks. Following the end of treatment, patients with a confirmed complete response, partial response or stable disease will be followed for up to 2 years to assess time to disease progression. Approximately 80 patients with documented diagnosis of B-cell CLL by standard clinical and immunophenotyping criteria will be enrolled into the SDX-101-03 study. This study is being conducted in the following European countries: France, Germany, Poland, Sweden and the United Kingdom.
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
- •Diagnosis of B-cell CLL by standard clinical and immunophenotypic criteria as specified by the NCI working group revised guidelines for diagnosis and treatment of CLL(32).
- •Binet stages A-C with evidence of active disease requiring treatment by the presence of one or more of the following at the time of study entry:
- •Disease related B symptoms (Fever > 38C [100.5F] for ≥ 2 weeks without evidence of infection, night sweats without evidence of infection, weight loss > 10% within previous 6 mo.).
- •Evidence of progressive marrow failure as manifested by:
- •A decrease in hemoglobin to < 10g/dL, or
- •A decrease in platelet count to < 100 x 10(9)/L within the previous 6 months, or
- •A decrease in absolute neutrophil count (ANC) to < 1.0 x 10(9)/L within 6 months
- •Progressive lymphocytosis with an increase of > 50% over a 2 month period, or an anticipated doubling time of < 6 months.
- •Massive nodes or clusters(i.e., > 10 cm in longest diameter) or progressive lymphadenopathy.
- •Progressive splenomegaly to > 2cm below the left costal margin or other organomegaly with progressive increase over 2 consecutive clinical visits ≥ 2 weeks apart.
- •No prior chemotherapy for CLL.
- •Age ≥ 18 at signing of informed consent.
- •World Health Organization (WHO) performance status ≤ 0-2 (Appendix B).
- •Platelet count > 50,000/μL, hemoglobin > 8.0 g/dl and absolute neutrophil count > 1000/μL.
- •Renal function ≤ 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine)
- •Liver function ≤ 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values).
- •Female patients of childbearing potential must have a negative pregnancy test (serum or urine Beta-human chorionic gonadotropin, Beta-HCG); men and women of reproductive potential must employ effective contraceptive methods while on study therapy, and for 2 months following completion of treatment.
- •Signed EC/IRB-approved informed consent by patient prior to all study related procedures.
排除标准
- •Active autoimmune manifestation of CLL such as ongoing hemolytic anemia or ITP
- •History of a second malignancy with the exception of cervical cancer,or resected basal cell carcinoma or other malignancies with no evidence of recurrence 5 or more years since diagnosis.
- •Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV).
- •Transformation to an aggressive B-cell malignancy such as Richter's transformation, prolymphocytic leukemia (PLL) or large B-cell lymphoma.
- •Clinical evidence of CNS involvement with CLL.
- •Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of the study objectives.
- •Treatment with any investigational agent within 4 weeks of study entry.
- •The use of steroids, nonsteroidal anti-inflammatory drugs, regardless of indication (excluding prophylactic use of aspirin for prevention of acute myocardial infarction or stroke)
- •Pregnancy or currently breast feeding.
研究组 & 干预措施
Chlorambucil
Experimental
Regime A
干预措施: Chlorambucil (Drug)
R-etodolac with chlorambucil
Experimental
Regime B
干预措施: R-etodolac + chlorambucil (Drug)
结局指标
主要结局
Bone Marrow Biopsy or Aspiration
时间窗: Baseline + 6 months
Overall response rate assessment according to National Cancer Institute-Working Group (NCI-WG) criteria using cytogenetic and biomarker evaluations.
次要结局
- Cytogenetic and biomarker evaluations + adverse events(6 months)
研究者
研究点 (22)
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