EUCTR2011-004672-11-BE进行中（未招募）1 期
A multi-centre, open label, uncontrolled, Phase IIa clinical trial evaluating the safety and efficiacy of NOX-A12 in combination with a background therapy of bendamustine and rituximab (BR) in previously treated patients with chronic lymphocytic leukemia (CLL). - NOX-A12 with a background therapy of bendamustine and rituximab in C
OXXON Pharma AG0 个研究点目标入组 33 人开始时间: 2012年2月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
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. Male of female, age = 18
- •2. Diagnosis of B cell CLL
- •3. Relapsed, bendamustine-sensitive (at least partial response with a duration of at least six months) or bendamustine-naive patients after at least one but not more than 3 prior treatments of their disease.
- •4. CLL in need of treatment (Binet C or A/B with active disease) according to the IWCLL guidelines
- •5. Subject must have measurable disease according to IWCLL guidelines
- •6. Pre-study WHO performance status of = 2 and modified cumulative illness rating scale (CIRS) of less than 7
- •7. Signed and dated, written informed consent
- •8. Men and women of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment. Medically acceptable methods of birth control are methods with a low failure rate of less than 1% per year; e.g. hormonal contraceptives for at least the 7 days before trial enrolment or an interuterine device, or double barrier method (male or female condom or diaphragm, in combination with a spermicidal gel). All women, including those with tubal ligation, are considered to be of childbearing potential unless they have been postmenopausal for at least 2 years. Hysterectomized women are considered surgically sterile and are not required to use any contraception.
- •9. Acceptable liver function at screening: bilirubin =1.5 x ULN, AST and/or ALT = 2.5 x ULN
- •10. Acceptable heamatological status: platelet count = 75 x10 9/L, ANC > 0.75 x 10 9/L
- •11. Acceptable renal function: serum creatinine =1.5 ULN and/or creatinine clearance = 50 ml/min (Cockcroft Gault formula)
- •12. No clinical significant abnormalities of liver volume, liver heamodynamics or elasticity, measured by abdominal ultrasound.
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1. Relapse of B-cell CLL within 6 months after last chemotherapy
- •2. Subjects who have progressed to more aggressive B-cell cancers such as Richter's syndrome
- •3. CLL with either deletion of the short arm of chromosome 17 (17p-) or mutations associated with the loss of p53
- •4. The subject has a history of or is clinically suspicious of cancer related CNS disease
- •5. Patients at risk of hemostasis or spleen rupture
- •6. Autoimmune hemolytic anemia
- •7. Prior allogeneic stem cell transplant or patients who are considered to be candidates for allo SCT as assessed by their treating physician
- •8. Patient has a history of other active malignancies within three years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confirmed and surgically resected with curative intent.
- •9. The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration
- •10. Female subject is pregnant or breast feeding
- •11. Known infection with HIV, active Hepatitis B or Hepatitis C
- •12. The patient has a history of prior toxicity from bendamustine or rituximab that resulted in permanent discontinuation of treatments.
- •13. Treatment with other investigational drugs, or participation in another clinical trial within 30 days prior to study drug administration
- •14. Uncontrolled hypertension (defined as systolic blood pressure (BP) > 160 mmHg or diastolic BP >100mmHg)
- •15. Myocardial infarction or unstable angina within the past 6 months prior to study drug administration. Heart failure of New York Heart Association functional Class III or IV prior to study drug administration.
- •16. Systemic illnesses or other severe concurrent disease including alcoholism which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatment
- •17. Known or suspected of not being able to comply with the trial protocol
- •18. Having previously enrolled in this clinical trial
- •19. Known hypersensitivity to rituximab or to any of the excipients or to murine proteins
- •20. History of recurring or chronic infections or underlying conditions which may further predispose patients to serious infection
- •21. Known hypersensitivity to bendamustine or to mannitol
- •22. Invasive surgery within 30 days prior to study drug administration
研究者
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