RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED PTCLU AND CUTANEOUS T-CELL LYMPHOMA CTCL MedDRA version: 6.1 Level: PT Classification code 10034626
Conditions
Interventions
Trade Name: VELCADE 1FL 3,5MG
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bortezomib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the feasibility of Bortezomib as salvage treatment;Secondary Objective: to assess the overall response rate complete remission and partial remission of patients with PTCLU and CTCL receiving Bortezomib;to assess the toxicity profile of this treatment;to assess the quality of life.;Primary end point(s): tumor response criteria Cheson | — |
Countries
Italy
Outcome results
None listed