Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma (PTCL)

Inclusion Criteria:

• Disease Characteristics:

  • Diagnosis of peripheral T-cell:

    • Any stage disease allowed
  • At least 1 objective measurable disease parameter

  • No anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma

    • ALK-negative T-cell large cell lymphoma allowed

  • No cutaneous T-cell lymphoma

    • No sezary syndrome
    • No NK/T cell lymphoma
  • No history of or current radiographic evidence of CNS metastasis, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement

• Patient Characteristics:

  • Age:

    • 18 -75 years

  • Performance status:

    • ECOG 0-2

  • Life expectancy:

    • No less than 12 weeks

  • Hematopoietic:

    • Absolute neutrophil count ≥ 1,500/mm^3
    • Hemoglobulin ≥ 80*10^12/L
    • Platelet count ≥ 100,000/mm^3
    • No evidence of bleeding diathesis or coagulopathy

  • Hepatic:

    • Bilirubin ≤ 1.5 mg/dL
    • AST ≤ 2.5 times ULN
    • PT, INR, and PTT ≤ 1.5 times normal

  • Renal:

    • Creatinine ≤ 1.5 times normal

  • Cardiovascular:

    • No cerebrovascular accident within the past 6 months
    • No myocardial infarction within the past 6 months
    • No unstable angina within the past 6 months
    • No New York Heart Association class II-IV congestive heart failure
    • No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg)
    • No other clinically significant cardiovascular or peripheral vascular disease
    • LVEF is normal

  • Other:

    • Not pregnant or nursing
    • Fertile patients must use effective contraception
    • No history of active seizures
    • No non-healing ulcer (unless involved with lymphoma)
    • No active infection requiring parenteral antibiotics
    • No known HIV positivity
    • No other active malignancy within the past 6 months except carcinoma in situ of the cervix or basal cell carcinoma of the skin

• PRIOR CONCURRENT THERAPY:

  • Biologic therapy:

    • Not specified

  • Chemotherapy:

    • No prior chemotherapy was allowed

  • Surgery:

    • More than 4 weeks since prior major invasive surgery or open biopsy
    • At least 7 days since prior minor surgery
    • No concurrent major surgery

Exclusion Criteria:

• Prior treatment included chemotherapy and radiotherapy
• With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)
• Pregnant or nursing
• Other currently active malignancy except nonmelanoma skin cancer
• Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
• Hypersensitivity to albumen