Primary therapy of patients with Alk-negative T-NHL in patients aged 61 - 80 years ICD classification codes : ICD-O 9702/3
Conditions
Interventions
Trade Name: MabCampath
Product Name: alemtuzumab
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
University Medicine Goettingen
Eligibility
Sex/Gender
All
Inclusion criteria
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, exept stage I with no further IPI risk factor (LDH, ECOG, stage, E>1) beside 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 ALK-positive 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-cell lymphoma of the AILD 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Stage I with IPI 0 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 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 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) 14. Non-conformity to eligibility criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of the efficacy of chemotherapy with CHOP-14 by the additional use of the CD52 monoclonal antibody alemtuzumab measured on the basis of Event-free Survival;Secondary Objective: Comparison of +/- alemtuzumab addition concerning further endpoints of efficacy, short term and long term side effects, adherence to protocol and withdrawal from therapy;Primary end point(s): event-free survival (EFS) at 3 years | — |
Countries
Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden
Outcome results
None listed