NCT01144260已完成2 期
A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
CytRx2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年6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
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate the response rate (complete and partial), in subjects with relapsed or refractory B-Cell CLL
研究概览
简要总结
A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL).
详细描述
Bafetinib is a dual protein kinase inhibitor, targeting both bcr/abl and Lyn kinases. B-cell chronic lymphocytic leukemia cells overexpress Lyn kinase compared to normal B lymphocytes as well as acute leukemias (ALL and AML), and inhibition of Lyn kinase induces apoptosis in cultures of B-CLL cells. Thus, bafetinib may stop the growth of B-CLL cells by inhibiting Lyn kinase, the molecule that couples the B cell receptor to downstream signaling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age ≥18 years, male or female.
- •B-cell chronic lymphocytic leukemia meeting the WHO criteria.
- •Relapsed or refractory disease with at least one of the following criteria: *progression after at least one course of a purine nucleoside analog (fludarabine phosphate, cladribine, pentostatin)
- •progression after at least one course of an alkylating agent (cyclophosphamide or chlorambucil)
- •relapse within 12 months after at least one course of either a purine nucleoside or an alkylating agent.
- •Capable of providing informed consent and complying with trial procedures.
- •ECOG performance status 0-
- •Requires chemotherapy for disease as shown by any of the following criteria:
- •measurable and progressive lymphocytosis
- •measurable and progressive lymphadenopathy (lymph node ≥2 cm in a single diameter)
- •either weight loss ≥10% within the past 6 months or extreme fatigue due to leukemia
- •fevers ≥100.5 degrees F for 2 weeks with no source of infection
- •night sweats with no evidence of infection
- •progressive marrow failure (worsening anemia with hemoglobin <10 gm/dL and/or thrombocytopenia with platelet count <100,000/mm3)
- •massive or progressive splenomegaly (spleen >6 cm below left costal margin).
- •Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. [Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.]
- •Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- •Accessibility to the site.
排除标准
- •Chemotherapy, antibody therapy, surgery within 4 weeks of study enrollment.
- •Exposure to any investigational agent within 30 days of the Screening Visit.
- •Known CNS disease.
- •Concurrent active malignancies except basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.
- •Laboratory values: Screening creatinine clearance (calculated by Cockcroft Gault formula) of less than 50 mL/minute, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count <3500/mm3, absolute neutrophil count <1000/mm3, hematocrit level <33% for females or <35% for males.
- •Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines.
- •Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- •History or signs of active coronary artery disease with or without angina pectoris.
- •Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted.
- •Known HIV infection.
- •Uncontrolled active, infection.
- •Major surgery within 3 weeks prior to treatment.
- •Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- •Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study.
研究组 & 干预措施
Bafetinib
Experimental
干预措施: bafetinib (Drug)
结局指标
主要结局
To evaluate the response rate (complete and partial), in subjects with relapsed or refractory B-Cell CLL
时间窗: Upto 6 months or disease progression
次要结局
- Adverse Events(1 year)
研究者
研究点 (2)
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