Clinical trial NCT01307592 (phase 2, status: unknown status)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: gemcitabine hydrochloride, lenalidomide, oxaliplatin
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed aggressive non-Hodgkin lymphoma, including
             any of the following subtypes:

               -  Follicular large cell lymphoma

               -  Diffuse large cell lymphoma

               -  Peripheral T-cell lymphoma

               -  Transformed lymphoma

               -  Lymphoblastic lymphoma

               -  Burkitt or Burkitt-like lymphoma

          -  Refractory or relapsed disease meeting the following criteria:

               -  Patients who either did not respond to prior therapy or whose best response was
                  partial response after ≥ 4 courses of chemotherapy

               -  Histologic confirmation of relapsed or refractory disease is desirable but not
                  mandatory and will be left to the discretion of the investigator

          -  Must have evaluable or measurable disease

          -  Patients who are candidates for stem cell or bone marrow transplantation allowed

          -  No CNS involvement by lymphoma

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-3

          -  Absolute neutrophil count ≥ 1,000/mm³ (unless due to marrow infiltration by lymphoma)

          -  Platelet count ≥ 100,000/mm³ (unless thrombocytopenia is due to marrow infiltration by
             lymphoma)

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless liver is involved with
             lymphoma, hemolysis, or Gilbert syndrome)

          -  Serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 30 ml/min (unless creatinine
             elevation is due to lymphoma)

          -  ALT ≤ 2 times ULN (≤ 5 times ULN if liver metastasis is involved with lymphoma)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective double-method contraception for ≥ 28 days before,
             during, and for ≥ 28 days after completion of study therapy

               -  Men must use latex condoms even after a successful vasectomy

          -  Must be enrolled in the mandatory RevAssist® program and be willing to comply with its
             requirements

          -  No neurosensory or neuromotor dysfunction ≥ grade 3

          -  No known HIV positivity or active hepatitis B or C (hepatitis B surface antigen
             positivity or hepatitis C RNA positivity)

          -  No known hypersensitivity to thalidomide or erythema nodosum characterized by
             desquamating rash while taking thalidomide or other similar drugs

          -  No history of allergy to platinum or any of its derivatives or E. coli-derived
             products

          -  No other malignancies within the past 5 years, except treated basal cell or squamous
             cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or any
             surgically cured malignancy from which the patient has been disease-free for ≥ 5 years

          -  No NYHA class III-IV congestive heat failure (no symptoms on less than ordinary
             exertion or at rest)

          -  No uncontrolled or intercurrent disease, including any of the following:

               -  Arrhythmias

               -  Angina pectoris

               -  Active infection or fever > 38.2 C (unless due to lymphoma)

          -  No serious medical condition, laboratory abnormality, or psychiatric illness that
             would place patient at risk in study or confound ability to interpret study data

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior gemcitabine hydrochloride, oxaliplatin, or lenalidomide

          -  Prior rituximab allowed

          -  No more than 4 prior regimens of chemotherapy allowed, including stem cell or bone
             marrow transplantation

          -  More than 2 weeks since prior and no concurrent anticancer therapy, including
             radiotherapy, hormonal therapy, or surgery

          -  More than 3 weeks since prior chemotherapy or radiotherapy

          -  More than 28 days since prior and no other concurrent investigational drug trial or
             investigational agent

          -  Able to take aspirin (81 mg or 325 mg) daily or low molecular weight heparin as
             prophylactic anticoagulation

          -  No concurrent thalidomide