Clinical trial NCT00064116 (phase 3, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: chop regimen
SMILES: CCO
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL
             classification

               -  Diagnosed within the past 6 weeks

               -  CD20+ disease

               -  Ann Arbor stage II, III, or IV disease or stage I bulky disease

          -  International Prognostic Index (IPI) score of 0 or 1

               -  Score 0 defined by all of the following:

                    -  Stage I or II disease

                    -  ECOG performance status of 0 or 1

                    -  Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN)

               -  Score 1 defined by 1 of the following:

                    -  Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater
                       than ULN

                    -  Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater
                       than ULN

                    -  Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater
                       than ULN

          -  Previously untreated disease

          -  Mediastinal B-cell lymphoma allowed

          -  No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies

          -  No transformed lymphoma

          -  No primary CNS lymphoma

          -  No primary gastrointestinal (MALT) lymphoma

          -  No post-transplant lymphoproliferative disorder

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 60

        Performance status

          -  See Disease Characteristics

          -  ECOG 0-3

        Life expectancy

          -  At least 3 months

        Hematopoietic

          -  Not specified

        Hepatic

          -  Bilirubin no greater than 2.0 mg/dL*

          -  Transaminases no greater than 3 times normal*

          -  No active chronic hepatitis B or C infection NOTE: *Unless related to lymphoma

        Renal

          -  Creatinine no greater than 2 times normal* NOTE: *Unless related to lymphoma

        Cardiovascular

          -  No myocardial infarction within the past 6 months

          -  No uncompensated heart failure

          -  No dilatative cardiomyopathy

          -  No coronary heart disease with ST segment depression on ECG

          -  No severe uncompensated hypertension

        Pulmonary

          -  No chronic lung disease with hypoxemia

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No known allergic reactions against foreign proteins

          -  No other prior malignancy except basal cell skin cancer or carcinoma in situ of the
             cervix

          -  No concurrent disease that would preclude study treatment

          -  No active infections requiring systemic antibiotics or antiviral medications

          -  No severe uncompensated diabetes mellitus

          -  No clinical signs of cerebral dysfunction

          -  No severe psychiatric disease

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior murine antibodies

        Chemotherapy

          -  No other concurrent anticancer chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No concurrent response-adapted (slow response or unconfirmed complete response)
             radiotherapy

        Surgery

          -  Not specified

        Other

          -  No prior lymphoma-specific treatment

          -  More than 12 weeks since prior participation in another clinical trial

          -  No prior participation in this study

          -  No other concurrent study medication