Phase II Study of VELCADETM in patientswith extranodal marginal zone B-cell lymphoma ofMALT-type pretreated with more than one prior systemictherapy regimen (X05142)

International Extranodal Lymphoma Study Group0 个研究点目标入组 35 人开始时间: 2006年5月23日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. histologically proven diagnosis of marginal zone B-cell lymphoma of MALT type arisen at
•any extranodal site
•2. any stage (Ann Arbor I-IV) (see Appendix B)
•3. relapsed or refractory disease pretreated with > 1 prior chemotherapy regimen and/or anti-
•CD20 immunotherapy
•4. no evidence of histologic transformation to a high grade lymphoma
•5. measurable or evaluable disease
•6. age > 18 years
•7. full recovery from previous therapy, with life expectancy of at least 6 months
•8. ECOG performance status 0-2 (see Appendix C)
•9. for primary gastric localized H. pylori-positive disease at diagnosis:
•a. persistent disease 1 year after documented H. pylori infection eradication
•b. clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori
•infection eradication
•10. no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks
•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

•1. prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
•2. other investigational drugs with 14 days before enrollment
•3. evidence of symptomatic central nervous system (CNS) disease
•4. severe impairment of bone marrow function (ANC <1.0x109/L, PLT <30x109/L within 14 days before enrollment), unless due to lymphoma involvement
•5. evidence of grade 2 peripheral neuropathy within 14 days before enrollment
•6. known hypersensitivity to bortezomib, boron or mannitol
•7. pregnant or lactating status, confirmation that the subject is not pregnant must be
•established by a negative serum -human chorionic gonadotropin ( -hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women
•8. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

发起方

International Extranodal Lymphoma Study Group