Clinical trial NCT01397591 (phase 2, status: terminated)
Conditions: recurrent adult diffuse large cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle 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, 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, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    study closed by pi due to lower than expected accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have biopsy sample obtained within 6 months of study entry that:

          -  Is histologically confirmed DLBCL, MCL or FL, by an Oregon Health and Science
             University (OHSU) hematopathologist

          -  Retains expression of CD20+

          -  Patients must be refractory to or have recurrent disease after prior rituximab
             containing treatment; relapse or progression is defined according the International
             Working Group (IWG) response criteria

          -  FL patients must have disease-related symptoms, cytopenias, threatened end-organ
             function, bulky or progressive disease, or it is the patient's preference to be
             treated

          -  DLBCL and MCL patients must be either transplant ineligible or have refused high dose
             therapy

          -  Patients must have radiographically measurable disease, as defined by the IWG
             criteria; the same method of assessment used to measure each lesion at baseline must
             be used for all subsequent tumor measurements throughout the study

          -  There is no limit to the number of prior treatments

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Absolute neutrophil count >= 1.0 K/mm^3

          -  Platelets >= 50 K /mm^3

          -  Total bilirubin =< 1.5 x normal institutional limits, unless secondary to Gilbert's
             disease

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             (SGOT))/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase (SGPT))
             =< 2.5 x institutional upper limit of normal (ULN)

          -  Alkaline Phosphatase < 2.5 times ULN (unless due to disease involvement of the liver
             or bone marrow)

          -  Patients must be able to comply with study procedures and follow-up examinations

          -  Women of childbearing potential (not surgically sterile or < 12 months naturally
             post-menopausal) must be willing to use medically accepted method of contraception for
             the duration and 6 months following the end of the treatment; acceptable methods of
             contraception include abstinence, barrier method with spermicidal or hormonal
             contraceptive (oral, transdermal, implanted and injected) in conjunction with a
             barrier method

          -  Men who are not surgically sterile must practice abstinence or use a barrier method of
             birth control for the duration and 6 months following the end of treatment

          -  Patients must have the ability to understand and the willingness to sign a written
             informed consent document

        Exclusion Criteria:

          -  Subjects who have current active hepatic or biliary disease (with the exception of
             patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable
             chronic liver disease per investigator assessment)

          -  Patients who have had chemotherapy, antibody or radiotherapy within 4 weeks (6 weeks
             for nitrosoureas or mitomycin C); corticosteroids for symptom control are allowed up
             to 7 days of starting protocol treatment

          -  Patients may not have received any other investigational agents within 4 weeks, or may
             not be currently participating in any other interventional clinical study

          -  Prior treatment with ofatumumab or bortezomib

          -  Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months
             prior to start of therapy

          -  Diagnosis of another malignancy, unless the patient has been disease-free or at least
             5 years following the completion of curative intent therapy with the following
             exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or
             cervical intraepithelial neoplasia, regardless of the disease-free duration, are
             eligible for this study if definitive treatment for the condition has been completed;
             patients with organ-confined prostate cancer with no evidence of recurrent or
             progressive disease based on prostate-specific antigen (PSA) values are also eligible
             for this study if hormonal therapy has been initiated or a radical prostatectomy has
             been performed

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ofatumumab or bortezomib

          -  Peripheral neuropathy or neuropathic pain of Grade 2 or greater

          -  Chronic or current infectious disease requiring systemic antibiotics, antifungal, or
             anti-viral treatment such as, but not limited to, chronic renal infection, chronic
             chest infection with bronchiectasis and tuberculosis

          -  History of significant cerebrovascular disease in the past 6 months or ongoing event
             with active symptoms or sequelae

          -  Clinically significant cardiac disease including unstable angina, acute myocardial
             infarction within six months prior to randomization, congestive heart failure (New
             York Heart Association (NYHA) III-IV), and arrhythmia unless controlled by therapy,
             with the exception of extra systoles or minor conduction abnormalities

          -  Significant concurrent, uncontrolled medical condition including, but not limited to,
             renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
             psychiatric disease which in the opinion of the investigator may represent a risk for
             the patient

          -  Pregnant or breast feeding women

          -  Known human immunodeficiency virus (HIV) infection

          -  Positive serology for Hepatitis B (HB) defined as a positive test for HB surface
             antigen (HBsAg); in addition, if negative for HBsAG but HB core antibody (HBcAb)
             positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be
             performed; if positive the subject will be excluded

          -  Active hepatitis C infection (HC) defined as a positive test for hepatitis C antibody
             (HCAb), in which case the investigator should reflexively perform a HC Recombinant
             Immunoblot assay (RIBA) on the same sample to confirm the result

          -  Known lymphoma involvement of the central nervous system (CNS)