Clinical trial NCT00080847 (phase 2, status: terminated)
Conditions: contiguous stage ii adult diffuse large cell lymphoma, noncontiguous stage ii adult diffuse large cell lymphoma, stage iii adult diffuse large cell lymphoma, stage iv adult diffuse large 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
Drugs: cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have previously untreated stage III, IV, or bulky stage II diffuse
             large B-cell non-Hodgkin's lymphoma which is positive for CD20

          -  Adequate sections from the original diagnostic specimen must be available for
             submission for review; an adequate biopsy requires sufficient tissue to establish the
             architecture and a REAL or WHO histologic subtype with certainty; thus, core biopsies,
             especially multiple core biopsies MAY be adequate; whereas, needle aspirations or
             cytologies are not adequate

               -  Patients may also be registered to SWOG-8947 and SWOG-8819

          -  Patients must have an age-adjusted International Prognostic Index score of 0 or 1

          -  All patients must have bidimensionally measurable disease documented within 28 days
             prior to registration; patients with non-measurable disease in addition to measurable
             disease must have all non-measurable disease assessed within 42 days prior to
             registration

          -  Patients must have a unilateral bone marrow aspirate and biopsy performed within 42
             days prior to registration

          -  Patients must have a CT scan of the chest and abdomen/pelvis performed within 28 days
             prior to registration

          -  Patients must not have clinical evidence of central nervous system involvement by
             lymphoma; any laboratory or radiographic tests performed to assess CNS involvement
             must be negative within 42 days of registration

          -  Patients must not have a previous diagnosis of indolent lymphoma (histologic
             transformation are ineligible); as patients with nodal diffuse large ell lymphoma may
             have bone marrow involvement with small lymphocytes, such patients are eligible

          -  Patients must not have received prior chemotherapy, radiation, or antibody therapy for
             lymphoma

          -  All patients must have a Zubrod performance status of 0-2

          -  Serum LDH must be measured within 28 days prior to registration

          -  Patients must have a cardiac ejection fraction >= 45% by MUGA scan or an ECHO with no
             significant abnormalities within 42 days prior to registration

          -  Patients known to be HIV positive, or who have a history of solid organ
             transplantation are ineligible as the biology and natural history of HIV associated,
             or post transplant lymphomas are very different than that of de novo diffuse large
             cell lymphomas; patients at high risk of hepatitis B virus infection should be
             screened before initiation of rituximab

          -  Patients requiring continuing supplemental oxygen therapy are ineligible

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease-free for 5 years

          -  Pregnant or nursing women may not participate due to the potential for congenital
             abnormalities, and of harm to nursing infants due to this treatment regimen; women or
             men of reproductive potential may no participate unless they have agreed to use an
             effective contraceptive method

          -  If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next
             working day

               -  In calculating days of tests and measurements, the day a test or measurement is
                  done is considered day 0; therefore, if a test is done on a Monday, the Monday 4
                  weeks later would be considered day 28; this allows for efficient patient
                  scheduling without exceeding the guidelines

          -  All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines

          -  At the time of patient registration, the treating institution's name and ID number
             must be provided to the Data Operations Center in Seattle in order to ensure that the
             current (within 365 days) date of institutional review board approval for this study
             has been entered into the data base