Clinical trial NCT01321008 (phase 1/phase 2, status: terminated)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: cyclophosphamide, doxorubicin, vincristine, 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
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          1. Patients with newly diagnosed stage I and II nasal Natural Killer (NK) cell lymphoma.

          2. Adequate blood cell counts (i.e. Absolute neutrophil count (ANC)> 1000) at baseline,
             or willingness to accept supportive measures such as transfusions, filgrastim, and
             Epoetin. Epoetin will not be administered concurrently with radiation.

          3. Patients must have adequate liver function as indicated by: *Bilirubin </= 1.5 times
             the upper limit of normal (ULN), * Alanine transaminase (ALT) </= 2 times the (ULN) or
             aspartate transaminase (AST) ≤ 2 times the ULN, *These values must be obtained within
             two weeks before protocol entry.

          4. Patients are required to have adequate renal function as indicated by a serum
             creatinine </= 2.5 mg/dL.This value must be obtained within two weeks before protocol
             entry.

          5. Left ventricular ejection fraction must be evaluated by nuclear medicine scan or
             echocardiography and measure >/= 50%.

          6. Male patients must agree to use a barrier method of contraception or agree to abstain
             from heterosexual activity for the duration of the study.

          7. Female patients must be willing to use two adequate barrier methods of contraception
             to prevent pregnancy or agree to abstain from heterosexual activity throughout the
             study or be post menopausal (free from menses > two years or surgically sterilized).

          8. Female patients of childbearing potential must have a negative serum pregnancy test
             (BhCG) within 2 weeks of protocol entry.

          9. Patients must have the ability to give informed consent.

        Exclusion Criteria:

          1. Patients with active Hepatitis B and/or Hepatitis C infection.

          2. Patients with active infections requiring specific anti-infective therapy are not
             eligible until all signs of infections are resolved.

          3. Patients known to be HIV positive.

          4. Patients with pre-existing cardiovascular disease requiring ongoing treatment. This
             includes: a) Congestive heart failure class III/IV (CHF) per new york heart
             association (NYHA) criteria. b) Cardiomyopathy, c) Uncontrolled cardiac arrhythmia, d)
             Unstable angina pectoris, e) Recent Myocardial infarction (MI) (within 6 months).

          5. Patients with prior exposure to anthracyclines:

          6. Patients who are pregnant or breast-feeding.

          7. Patients with psychiatric illness and/or social situations that would limit compliance
             with the study medication and requirements.

          8. Prior radiation to the site of current primary disease, if re-treatment would lead to
             violation of known radiation dose tolerance limits for that site.