Phase II study of Proteasome inhibitor Bortezomib in patients with relapsed or refractory peripheral T-cell lymphoma unspecified PTCLU and cutaneous T-cell lymphoma CTCL - ND

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点目标入组 30 人开始时间: 2006年3月15日最近更新: 2012年3月19日

适应症

试验速览

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•Hystologically confirmed PTCLU or CTCL REAL/WHO Any stage, any IPI, any bone marrow status 2nd relapse or refractory patients 18 years ECOG PS 2 Hb 10 g/dL; Neutro 1.5x109/L; plt 100 x 109/L Normal hepatic, renal and cardiac functions Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
•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

•Patients meeting any of the following exclusion criteria are not to be enrolled in the study. Active CNS lymphoma HIV-related lymphoma CT or RT or anticancer 4 weeks HIV, HBV or HCV history Patient has a platelet count of platelet count 30 109/L within 14 days before enrollment. Patient has an absolute neutrophil count of ANC 1.0 109/L within 14 days before enrollment. Patient has a calculated or measured creatinine clearance 30 mL/minute within 14 days before enrollment. Patient has Grade 2 peripheral neuropathy within 14 days before enrollment. Patient has hypersensitivity to bortezomib, boron or mannitol. Female subject is pregnant or breast-feeding. 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. Patient has received other investigational drugs with 14 days before enrollment Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

发起方

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI