Clinical trial NCT00301821 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate
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, [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, 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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diffuse large B-cell lymphoma

               -  B-cell phenotype (CD20+) as determined by immunohistochemistry (IHC) or flow
                  cytometry

               -  Stage II, III, or IV disease

          -  CD22+ tumor by IHC*

        NOTE: *CD22 status may be determined after study enrollment

          -  Measurable disease, defined as at least 1 lesion ≥ 1.5 cm by CT scan or physical exam

          -  No relapsed or refractory non-Hodgkin's lymphoma

          -  No history of transformed lymphoma

          -  No CNS lymphoma

               -  CNS symptoms or bone marrow or sinus involvement must have absence of CNS
                  lymphoma confirmed by lumbar puncture

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3

             - For patients with ECOG PS 3, the PS must be disease related

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Total bilirubin ≤ 2 mg/dL (if total bilirubin > 2 mg/dL, direct bilirubin should be
             within normal limits)

          -  AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)

          -  Creatinine ≤ 2 times ULN

          -  Life expectancy ≥ 12 weeks

          -  Negative pregnancy test

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 12 months after
             completion of study treatment

          -  No active serious infection requiring antibiotics

          -  No New York Heart Association class III or IV heart disease

          -  No other primary malignancy within the past 5 years, except for squamous cell or basal
             cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated
             prostate cancer with a stable prostate-specific antigen

          -  No known HIV positivity

          -  No known hepatitis B or C infection

          -  Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history
             of heart disease or is ≥ 50 years old)

          -  Willing to provide blood and tissue samples for mandatory translational research
             component of study

        PRIOR CONCURRENT THERAPY:

          -  No prior therapy for diffuse large B-cell lymphoma, including the following:

               -  Chemotherapy

               -  Immunotherapy

               -  Biologic therapy

               -  Radiotherapy

          -  Prior short course (≤ 14 days) of corticosteroids allowed

          -  Prior splenectomy allowed

          -  No prior pelvic irradiation

          -  No other concurrent investigational agents

          -  No concurrent chemotherapy, immunotherapy, or radiotherapy

          -  No concurrent enrollment on another treatment study involving a pharmacologic agent
             (e.g., drugs, biologics, immunotherapy, or gene therapy)