Originele protocol

Inclusion criteria

  1. Age: 61 – 80 years
  2. Risk group: All risk groups, including stage I with bulk (≥ 7.5 cm) and stages II to IV, except stage I N without bulk and with no IPI risk factor besides the age over 60
  3. Histology: Diagnosis of aggressive non-Hodgkin’s lymphoma, confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement if there is no lymph node involvement. It will be possible to treat all peripheral T-lineage lymphomas with the exception of ALKpositive anaplastic large cell lymphoma and primary cutaneous T-cell lymphomas (Mycosis fungoides, Sezary syndrome and primary cutaneous CD30-positive lymphoproliferations, and transformed primary cutaneous T-cell lymphomas). These lymphomas comprise:
    T cell -NHL:
    peripheral T-cell lymphoma PTCL-NOS
    Lennert’s lymphoma
    T-zone lymphoma
    T-immunoblastic variant
    Perifollicular/follicular variant
    T-cell lymphoma of the AIL type
    anaplastic large cell lymphoma
    extranodal NK/T-cell lymphoma, nasal type
    intestinal T/NK-cell lymphoma (± enteropathy)
    hepatosplenic gamma-delta lymphoma
    subcutaneous panniculitis-like PTCL
  4. Performance status: Performance status ECOG 0 – 2 (Karnofsky index: 60 -100%). The general status of each patient is to be assessed at time of randomisation and can thus take place after initiation of prephase treatment. A performance status of ECOG 3 will allow inclusion, if it is lymphoma related. The pretreatment status is to be documented in the staging CRF; the performance after the prephase treatment is also to be documented in the relevant CRF for the prephase treatment (see Appendix). A definition of the performance status is provided in the Appendix.
  5. Declaration of center participation
  6. written consent of the patient
  7. measurable disease defined as at least one lesion with two measurable perpendicular diameters of which at least one should be >=15 mm

Exclusion criteria

  1. Stage I N with IPI 0 except age > 60 and without bulk
  2. Already initiated lymphoma therapy (except for the prephase treatment specified for this study)
  3. Serious accompanying disorder or impaired organ function, in particular:
    • Cardiac: angina pectoris CCS >2, cardiac failure NYHA >2 and/or EF <45% or FS<25% in echocardiography/nuclear medicine examination
    • Pulmonary: abnormal blood gases; 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
    • Renal: creatinine >2 times the upper reference limit, unless related to NHL
    • Hepatic: bilirubin >2 times the upper reference limit, unless related to NHL
    • Uncontrollable diabetes mellitus (prephase treatment with prednisone!)
  4. Platelets <100 000/mm3, leukocytes <2500/mm3
  5. Bone marrow involvement >25%
  6. Primary leukemic manifestation of the lymphoma
  7. Known hypersensitivity to the medications to be used, especially murine or chimeric antibodies
  8. Known HIV-positivity
  9. Active hepatitis infection, active CMV infection, active systemic fungal infection, active infection with mycobacterium tuberculosis or atypical tuberculosis
  10. Suspicion that patient compliance will be poor
  11. Simultaneous participation in any other study protocol
  12. Prior chemo- or radiotherapy for malignancy
  13. Other concomitant malignant disease (history of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma)