EUCTR2012-005223-32-AT进行中（未招募）1 期
A Phase II trial of Ofatumumab in patients with lymphoma of the of the mucosa associated lymphoid tissue (MALT-Lymphoma) - O-MA 1
Medizinische Universität Wien, Klinik für Innere Medizin I, Abt. Onkologie0 个研究点开始时间: 2013年8月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Histologically confirmed MALT lymphoma (CD20+) with measurable disease (stage I – IV)
- •Gastric lymphoma: First or greater relapse after surgery, radiation, chemotherapy or HP-eradication (patients judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication in case of HP-positive gastric lymphoma) or refractoriness/persistence to the said measures. HP-negative patients are directly eligible and no initial attempt with antibiotics is considered in daily practice, as efficacy is low.
- •Extragastric lymphoma: Measurable disease stage I - IV
- •Age > 18 years
- •Life expectancy of at least 3 months
- •Patient must be able to tolerate therapy, and have adequate cardiac, renal and liver function
- •ECOG status of ? 2
- •Patient must be capable of understanding the purpose of the study and have given written informed consent.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (high grade lymphoma”) - component
- •Loss of CD20-expression following prior therapy (only to be expected following therapy with rituximab or y90-ibritumomab-tiuxetan)
- •Use of any investigational agent within 28 days prior to initiation of treatment
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years
- •Major surgery, other than diagnostic surgery, within the last 4 weeks
- •Evidence of CNS involvement
- •A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
- •Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment
- •Inadequate hematological status at baseline prior to study entry:
- •Dependency on red blood cell and/or platelet transfusions
- •ANC (absolute neutrophil count (segmented + bands) <1.0 x 109/L; platelets <50 x 109/L ; creatinine >2.0 times upper normal limit
- •hepatic dysfunction: total bilirubin >1.5 times upper normal limit (unless due to DLBCL involvement of liver or a known history of Gilbert’s disease); ALT >2.5 times upper normal limit (unless due to disease involvement of liver); alkaline phosphatase >2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow)
- •Patients with active opportunistic infections
- •Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C
- •Positive serology for hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HB DNA test will be performed and if positive the subject will be excluded. Note: If HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included.
- •Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result.
- •Known HIV positivity
- •Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening. pregnancy testing must be performed within 7 days of administration of IMP. GSKs approved methods of birth control must be used
- •Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
- •Male subjects unable or unwilling to use adequate contraception methods from study start to one year af
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