Bortezomib, Rituximab, and Dexamethasone (BORID), followed by Rituximab maintenance, for patients with relapsed/refractory mantle cell lymphoma - BORID in relapsed mantle cell lymphoma

Medical University Vienna, Dept. of Medicine I, Clinical Division of Oncology0 个研究点目标入组 16 人开始时间: 2004年11月17日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•·Patients with histologically confirmed diagnosis of CD20-positive mantle cell lymphoma, who were previously treated with at least one line of standard therapy (CHOP or CHOP-like chemotherapy)·
•Ann Arbor Stage II-IV·
•Age 19 – 75 years·
•ECOG performance status of 0,1 or 2.·
•Measurable disease·
•Adequate cardiac, renal and liver function tests.·
•Absolute neutrophil count (ANC) > 1.0 x 109/L, and platelet count > 50 x 109/L (unless both are attributed directly to bone marrow involvement or auto-immune disease secondary to lymphoma)·
•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

•·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.·
•Clinically significant peripheral neuropathy (grade II or greater) ·
•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·
•Evidence of any severe active acute or chronic infection.·
•HIV-positive, Hbs-antigen positive, or HCV-RNA-positive patients.

发起方

Medical University Vienna, Dept. of Medicine I, Clinical Division of Oncology