Clinical trial NCT01300793 (phase 1, status: terminated)
Conditions: non-hodgkin's lymphoma, b-cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: velcade (bortezomib), rituximab, ifosfamide, carboplatin, etoposide
SMILES: ClCCNP1(=O)OCCCN1CCCl
Reason stopped: 
    closed for low accrual and no data is available.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Aggressive B-cell non-Hodgkin lymphoma, CD-20 positive, in first relapse or refractory
             to first- or second-line chemotherapy (non-platinum)

               -  Diffuse large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma (Grade
                  III), Transformed Follicular Lymphoma

               -  Prior Rituximab is allowed

               -  Prior radiation is allowed

               -  Prior autologous stem cell transplant is allowed

          -  Age 18-70 years

          -  ECOG performance status 0-2

          -  HIV seronegative

          -  No CNS involvement: CSF cytology is required for cases with bone marrow involvement,
             involvement of 2 or more extranodal sites, presentation in the testes or paranasal
             sinuses, or if any clinical suspicion of CNS involvement (e.g., cranial nerve
             deficits)

          -  Measurable disease on CT scan by international working group response criteria •
             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             not part of normal medical care, with the understanding that consent may be withdrawn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 (i.e., 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.

        Exclusion Criteria:

          -  Subject has a platelet count of less than 75,000.

          -  Subject has an absolute neutrophil count of less than 1000

          -  Subject has a calculated or measured creatinine clearance of <60 mL/minute within 14
             days before enrollment.

          -  Subject has grade 2 or greater peripheral neuropathy or grade 1 with pain within 14
             days before enrollment.

          -  Myocardial infarction within 6 months prior to enrollment or has New York Hospital
             Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities. Prior to study entry, any ECG
             abnormality at Screening has to be documented by the investigator as not medically
             relevant.

          -  Subject 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 pregnancy test result obtained during
             screening. Pregnancy testing is not required for post-menopausal or surgically
             sterilized women.

          -  Subject has been treated with more than two prior chemotherapy regimens

          -  Subject has been treated with a platinum-based regimen.

          -  Subject has received other investigational drugs with 14 days before enrollment

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