Inclusion criteria
- Age: 61 – 80 years
- 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
- 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
ALK-
extranodal NK/T-cell lymphoma, nasal type
intestinal T/NK-cell lymphoma (± enteropathy)
hepatosplenic gamma-delta lymphoma
subcutaneous panniculitis-like PTCL - 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.
- Declaration of center participation
- written consent of the patient
- measurable disease defined as at least one lesion with two measurable perpendicular diameters of which at least one should be >=15 mm
Exclusion criteria
- Stage I N with IPI 0 except age > 60 and without bulk
- Already initiated lymphoma therapy (except for the prephase treatment specified for this study)
- 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!)
- Platelets <100 000/mm3, leukocytes <2500/mm3
- Bone marrow involvement >25%
- Primary leukemic manifestation of the lymphoma
- Known hypersensitivity to the medications to be used, especially murine or chimeric antibodies
- Known HIV-positivity
- Active hepatitis infection, active CMV infection, active systemic fungal infection, active infection with mycobacterium tuberculosis or atypical tuberculosis
- Suspicion that patient compliance will be poor
- Simultaneous participation in any other study protocol
- Prior chemo- or radiotherapy for malignancy
- Other concomitant malignant disease (history of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma)