EUCTR2004-000440-24-SE进行中（未招募）不适用
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) -
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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. 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.
- •2. 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 < 12 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.
- •3.No prior chemotherapy for CLL.
- •4.Age = 18 at signing of informed consent.
- •5.World Health Organization (WHO) performance status 0-2.
- •6.Platelet count > 50,000/µL, hemoglobin > 8.0 g/dl and absolute neutrophil count > 1000/µL.
- •7.Renal function = 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine)
- •8.Liver function = 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values).
- •9.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.
- •10.Signed EC/IRB-approved informed consent by patient prior to all study related 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.Active autoimmune manifestation of CLL such as ongoing hemolytic anemia or ITP
- •2.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.
- •3.Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV).
- •4.Transformation to an aggressive B-cell malignancy such as Richter’s transformation, prolymphocytic leukemia (PLL) or large B-cell lymphoma.
- •5.Clinical evidence of CNS involvement with CLL.
- •6.Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of the study objectives.
- •7.Treatment with any investigational agent within 4 weeks of study entry.
- •8.The use of steroids, nonsteriodal anti-inflammatory drugs, regardless of indication (excluding prophylactic use of aspirin for prevention of acute myocardial infarction or stroke)
- •9.Pregnancy or currently breast feeding
研究者
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