Clinical trial NCT00377052 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bortezomib, gemcitabine hydrochloride
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed mantle cell lymphoma

               -  Relapsed disease

          -  Not refractory to prior therapy

               -  Must have received 1-3 prior systemic chemotherapy regimens AND has had no
                  disease progression while receiving chemotherapy or within 1 month of last dose
                  of most recent therapy

          -  Clinically and/or radiologically documented disease

               -  At least 1 site of disease must be bidimensionally measurable by CT scan or MRI
                  with ≥ 1 lesion meeting 1 of the following criteria:

                    -  Lymph nodes ≥ 1.5 cm x 1.5 cm by spiral CT scan

                    -  Non-nodal lesion ≥ 1 cm x 1 cm by MRI, CT scan, or physical exam

               -  No nonmeasurable disease only

          -  No preexisting ascites or pleural effusion ≥ grade 2

          -  No known CNS involvement by lymphoma

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  Absolute granulocyte count ≥ 1,500/mm³

          -  Platelet count ≥ 75,000/mm³

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN

          -  AST or ALT ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  LVEF ≥ 45% by echocardiogram or MUGA

          -  No history of allergic reactions attributed to compounds containing boron or mannitol

          -  No preexisting edema ≥ grade 2

          -  No preexisting neuropathy (sensory and/or pain) ≥ grade 2

          -  No preexisting shortness of breath ≥ grade 2

          -  No history of other malignancies, except adequately treated nonmelanoma skin cancer,
             curatively treated in situ cancer of the cervix, or other solid tumors curatively
             treated with no evidence of disease for ≥ 5 years

          -  No other serious illness or medical condition that would preclude compliance with
             study requirements, including any of the following:

               -  Serious uncontrolled infection

               -  Uncontrolled or severe cardiovascular disease, including any of the following:

                    -  Myocardial infarction within the past 6 months

                    -  New York Heart Association class III-IV heart failure

                    -  Uncontrolled angina

                    -  Clinically significant pericardial disease

                    -  Cardiac amyloidosis

               -  Significant neurological disorder

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 6 weeks since prior chemotherapy

          -  No prior radioactive monoclonal antibody therapy

          -  No prior bortezomib

          -  No prior investigational therapy (except for flavopiridol)

          -  No prior radiotherapy to > 25% of functioning bone marrow

          -  At least 4 weeks since prior radiotherapy and recovered

               -  Low-dose, nonmyelosuppressive radiotherapy may be allowed

          -  At least 2 weeks since prior major surgery

          -  No other concurrent anticancer therapy

          -  No concurrent corticosteroids

          -  No other concurrent cytotoxic chemotherapy

          -  No other concurrent investigational agents