Clinical trial NCT00217425 (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, prednisone, vincristine
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:

        INCLUSION CRITERIA:

          -  Diagnosis of peripheral T-cell or natural killer cell neoplasm

               -  Any stage disease allowed

               -  HTLV-positive tumors allowed

          -  At least one objective measurable disease parameter. Abnormal positron emission
             tomography scans are not considered evidence of measurable disease unless results are
             confirmed by CT scan or other appropriate imaging techniques

          -  Age 18 and over

          -  ECOG Performance status 0-2

          -  Absolute neutrophil count ≥ 1,000/mm^3(500/mm^3 if due to bone marrow involvement with
             lymphoma)

          -  Platelet count ≥ 100,000/mm^3(50,000/mm^3 if due to bone marrow involvement with
             lymphoma)

          -  Bilirubin ≤ 2.0 mg/dL (≤ 3 times upper limit of normal [ULN] if due to hepatic
             involvement with lymphoma)

          -  AST ≤ 2 times ULN (5 times ULN if due to hepatic involvement with lymphoma)

          -  PT, INR, and PTT ≤ 1.5 times normal

          -  Creatinine ≤ 2.0 mg/dL

          -  Urinary protein:creatinine ratio ≤ 1

          -  History of deep venous thrombosis allowed provided patient is on a stable dose of
             anticoagulants for at least 2 weeks prior to study entry

          -  LVEF ≥ 50%

          -  History of pulmonary embolism allowed provided patient is on a stable dose of
             anticoagulants for at least 2 weeks prior to study entry

          -  One prior cycle of CHOP for PTCL allowed

          -  More than 4 weeks since prior major invasive surgery or open biopsy

          -  At least 7 days since prior minor surgery. Peripheral lymph node core biopsy, bone
             marrow biopsy, fine needle aspiration, skin biopsy, or central line placement are not
             considered minor surgical procedures

          -  More than 7 days since prior and no concurrent anti-platelet drugs (e.g., ticlopidine,
             clopidogrel, or cilostazol) except aspirin or other nonsteroidal anti-inflammatory
             drugs

          -  Concurrent anticoagulants allowed provided patient is on a stable dose

               -  INR must be stable for at least 2 weeks prior to study entry

               -  PT/INR and/or PTT must be closely monitored and levels kept within acceptable
                  range for underlying thrombotic disease

               -  Concurrent heparin flush for maintenance of central line patency allowed

        EXCLUSION CRITERIA:

          -  Anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma. ALK-negative
             T-cell large cell lymphoma allowed

          -  Cutaneous T-cell lymphoma

          -  History of or current radiographic evidence of CNS metastasis, including previously
             treated, resected, or asymptomatic brain lesions or leptomeningeal involvement

          -  Evidence of bleeding diathesis or coagulopathy

          -  Cerebrovascular accident within the past 6 months

          -  Myocardial infarction within the past 6 months

          -  Unstable angina within the past 6 months

          -  New York Heart Association class II-IV congestive heart failure

          -  Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic
             BP > 100 mm Hg)

          -  Other clinically significant cardiovascular or peripheral vascular disease

          -  Abdominal fistula within the past 6 months

          -  Gastrointestinal perforation within the past 6 months

          -  Intra-abdominal abscess within the past 6 months

          -  Concurrent major surgery

          -  Pregnant or nursing. Female patients must have negative pregnancy test. Fertile
             patients must use effective contraception

          -  History of active seizures

          -  Significant traumatic injury within the past 4 weeks

          -  Non-healing ulcer (unless involved with lymphoma)

          -  Bone fracture

          -  Active infection requiring parenteral antibiotics

          -  HIV positivity

          -  Other active malignancy within the past 6 months except carcinoma in situ of the
             cervix or basal cell carcinoma of the skin