Originele protocol

Inclusion criteria

  • Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of stage I bulk (>= 7.5 cm) and stages II to IV.
  • Patients with a confirmed histologic diagnosis of peripheral T-cell NHL according to the WHO classification (Appendix C):
    • Peripheral T-cell lymphoma, unspecified (PTCL NOS)
    • Angioimmunoblastic T-cell lymphoma
    • Enteropathy-type T-cell lymphoma
    • Subcutaneous panniculitis-like T-NHL
    • Hepatosplenic T-cell lymphoma
    • Extranodal NK/T cell lymphoma, nasal type
  • Age 18-60 years at the time of randomization
  • Life expectancy of 3 months or longer
  • ECOG performance status 0, 1 or 2 at randomization (see appendix D). PS 3 acceptable if lymphoma-related.
  • Measurable disease
  • Written informed consent

Exclusion criteria

  • Patients with NK/T-NHL of the following type:
    • Precursor T cell lymphoblastic lymphoma/ leukemia
    • All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL, HTVL1-pos ATL)
    • Alk-positive and negative anaplastic large cell lymphoma
    • Blastic NK cell lymphoma
    • Cutaneous T-cell lymphoma, transformed or not
  • Concurrent severe and/or uncontrolled medical disease (e.g.uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection), which could compromise participation in the study.
  • Known hypersensitivity to murine or chimeric antibodies or proteins
  • Severe cardiac dysfunction (NYHA classification II-IV) or LVEF < 45 %
  • Significant renal dysfunction (serum creatinin >2 times upper limit of normal), unless related to NHL
  • Significant hepatic dysfunction (total bilirubin > 2 times ULN or transaminases >= 2.5 times ULN), unless related to NHL
  • Impaired pulmonary functions; in this case, the patient is to be excluded if the resultant pulmonary function test shows FEV1<50% or a diffusion capacity <50% of the reference values
  • Suspected or documented central nervous system involvement by NHL
  • Patients known to be HIV-positive
  • Patients with active, uncontrolled infections, especially known seropositivity for HCV or HbsAg
  • Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of extranodal NK/T cell lymphoma, nasal type
  • History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
  • Unwillingness or inability to comply with the protocol
  • Simultaneous participation in any other study protocol
  • Pregnant and nursing women