Clinical trial NCT00136591 (phase 2, status: terminated)
Conditions: follicular lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bortezomib, bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    an arm closed due to lack of efficacy
  
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject 18 years or older.

          -  Initial diagnosis of follicular B-cell lymphoma (CD20+) (grades 1, 2, and 3 based on
             the World Health Organization 1997 classification), in first or subsequent relapse or
             progression after prior anti-neoplastic treatment including previous rituximab
             treatment. Relapse or progression since previous anti-neoplastic therapy must be
             documented by new lesions or objective evidence of progression of existing lesions.

          -  At least 1 measurable lymph node mass that is >1.5 cm in 2 perpendicular dimensions,
             and has not been previously irradiated or has grown since previous irradiation.

          -  No active central nervous system (CNS) lymphoma

          -  Karnofsky Performance Status (KPS) >50% (Eastern Cooperative Oncology Group [ECOG]
             0-2)

          -  The following laboratory values at screening, unless abnormalities are related to the
             lymphoma:

               -  Absolute neutrophil count (ANC) >1000 cells/dL;

               -  Platelets >50,000 cells/dL;

               -  Aspartate transaminase (AST) <3 x upper limit of normal (ULN);

               -  Alanine transaminase (ALT) <3 x ULN;

               -  Total bilirubin <2 x ULN;

               -  Creatinine level <150 µmol/L

          -  Toxic effects of previous therapy or surgery resolved to Grade 2 or better.

          -  Female subject is either post-menopausal or surgically sterilized or willing to use an
             acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
             device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
             duration of the study. Women are neither breast feeding nor pregnant for the duration
             of the study. Confirmation that the subject is not pregnant must be established by a
             negative serum beta-human chorionic gonadotropin pregnancy test result obtained during
             screening. Pregnancy testing is not required for post-menopausal or surgically
             sterilized women. Male subject agrees to use an acceptable method of contraception for
             the duration of the study.

          -  Voluntary signed informed consent before performance of any study-related procedure
             not part of normal medical care.

          -  Patient with minimum life expectancy of 3 months.

        Exclusion Criteria:

          -  Any other type of lymphoma.

          -  Previous treatment with Velcade™.

          -  Anti-neoplastic or experimental or radiation therapy within 3 weeks before Day 1 of
             Cycle 1.

          -  Major surgery within 2 weeks before Day 1 of Cycle 1.

          -  Rituximab, alemtuzumab (Mabcampath®), or other unconjugated therapeutic antibody
             within 10 weeks before Day 1 of Cycle 1.

          -  Nitrosoureas within 6 weeks before Day 1 of Cycle 1.

          -  Radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan
             (Zevalin™), or tositumomab (Bexxar®) within 10 weeks before Day 1 of Cycle 1.

          -  Peripheral neuropathy or neuropathic pain of Grade 3 or worse.

          -  History of allergic reaction attributable to compounds containing boron or mannitol.

          -  Diagnosed or treated for a malignancy other than non-Hodgkin's lymphoma (NHL) within 5
             years before Day 1 of Cycle 1, with the exception of complete resection of basal cell
             carcinoma, squamous cell carcinoma of the skin, or in situ malignancy.

          -  Active systemic infection requiring treatment.

          -  Previously known HIV positive serology.

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study.

          -  Concurrent treatment with another investigational agent.

          -  Adult patient under guardian.