PHASE II TRIAL OF BORTEZOMIB (VELCADE®) IN PATIENTS WITH ADVANCED OR RELAPSED LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT)

AKH Vienna0 个研究点目标入组 16 人开始时间: 2005年9月8日最近更新: 2016年11月7日

试验速览

暂无简介。

•Histologically verified diagnosis of MALT lymphoma of any localization
•Disseminated disease upon diagnosis or first or greater relapse after local therapy (including gastrectomy or any type of surgery or radiation), prior chemotherapy or HP-eradication. In addition, also patients judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication will be included in the study.
•Measurable disease
•Ann Arbor Stage I-IV
•ECOG performance status of 0,1 or 2 (see Appendix )
•Age between 19 and 80 years
•Life expectancy of at least 3 months
•Adequate cardiac, renal and liver function tests (LVEF > 50%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range, alkaline phosphatase < 2.5 x upper limit of normal range, serum bilirubin < 2.0 mg/dl)
•Patient must be willing and able to comply with the protocol for the entire study duration
•Women of child-bearing potential must have a negative pregnancy test and must agree to use effective contraception for the entire treatment period
•Patient’s 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Lymphoma histology other than MALT lymphoma or MALT lymphoma tranforming to diffuse large cell lymphoma (high grade lymphoma”)
•Use of any investigational agent in the month prior to inclusion
•History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 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 (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
•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
•Patients with active opportunistic infections
•Pregnancy

发起方

AKH Vienna