Clinical trial NCT00392834 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: cyclophosphamide, cytarabine, doxorubicin hydrochloride, etoposide, ifosfamide, leucovorin calcium, liposomal cytarabine, methotrexate, therapeutic hydrocortisone, vincristine sulfate
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, 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, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, N[C@@H](CCCNC(N)=N)C(O)=O, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, [H][C@@]12CC[C@](O)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=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 Burkitt's lymphoma (BL) or new WHO 2009 criteria B-cell
             lymphoma unclassified (with features intermediated between difuse large B-cell
             lymphoma and BL)

               -  Any stage disease

               -  Newly diagnosed disease

          -  Meets 1 of the following criteria for disease risk:

               -  Low-risk disease, defined by 1 of the following:

                    -  Stage I with a single focus of disease < 10 cm AND normal lactate
                       dehydrogenase (LDH) level

                    -  Totally resected intra-abdominal disease only AND normal LDH post surgery

               -  High-risk disease, defined as not meeting criteria for low-risk disease

          -  Measurable or nonmeasurable disease

          -  HIV-positive confirmed by enzyme-linked immunosorbent assay and Western blot OR by
             measurable HIV viral load

          -  No visceral Kaposi's sarcoma

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 40-100%

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  LVEF ≥ 50% by MUGA or echocardiogram

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

          -  Absolute neutrophil count ≥ 1,000/mm³

          -  Platelet count ≥ 50,000/mm³ (unless related to lymphoma)*

          -  Direct bilirubin ≤ 2.0 mg/dL OR total bilirubin ≤ 3.5 mg/dL AND direct bilirubin
             normal (if elevated bilirubin secondary to antiretroviral therapy)

          -  AST and ALT ≤ 3 times upper limit of normal

          -  No other malignancy within the past 5 years except curatively treated cutaneous basal
             cell or squamous cell carcinoma, carcinoma in situ of the cervix, or cutaneous
             Kaposi's sarcoma

          -  No other medical illness unrelated to non-Hodgkin's lymphoma, including any of the
             following:

               -  Uncontrolled infection (including opportunistic infection)

               -  Chronic renal insufficiency

               -  Myocardial infarction within the past 6 months

               -  Unstable angina

               -  Cardiac arrhythmias other than chronic atrial fibrillation

          -  Patients with active hepatitis B infection are eligible provided they receive
             concurrent dual antiviral therapy NOTE: *Patients with bone marrow involvement are
             eligible irrespective of blood count

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior therapy for this disease except for 1 of the following :

               -  Seven consecutive days of steroids alone or in combination with a non-CHOP
                  regimen necessary for patient stabilization (e.g., cyclophosphamide and steroids
                  steroids for normalization of disease-related hyperbilirubinemia)

               -  One course of CHOP or fractionated CHOP (e.g. CODOX) with or without rituximab

          -  No epoetin alfa or filgrastim (G-CSF) within 24 hours of study chemotherapy

          -  No concurrent zidovudine