Mature T-cell non-Hodgkin's lymphoma Cancer Other and unspecified types of non-Hodgkin's lymphoma
Conditions
Interventions
Patients with T-NHL meeting all eligibility criteria will be registered and treated with: 8 cycles of CHOP every 2 weeks plus G-CSF (Pegfilgrastim), combined with 24 administrations of Alemtuzumab (Ma
Sponsors
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed histologic diagnosis of T-cell non-Hodgkin's lymphoma (T-NHL) according to the World Health Organization (WHO) classification: 1.1. Extranodal NK/T cell lymphoma, nasal type 1.2. Enteropathy-type T-cell lymphoma (EATL), if measurable disease 1.3. Subcutaneous panniculitis-like T-NHL 1.4. Angioimmunoblastic T-cell lymphoma 1.5. Peripheral T-cell lymphoma, unspecified (T-NHL NOS) 2. Aged 18 - 65 years inclusive, either sex 3. Stage II or more 4. WHO performance status 0, 1 or 2 5. Measurable disease 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with NK/T-NHL of the following type: 1.1. Precursor T cell lymphoblastic lymphoma/leukaemia 1.2. All mature T cell leukaemias (T-PLL, ATLL, NK cell leukaemia, T-LGL) 1.3. Anaplastic large cell lymphoma 1.4. Hepatosplenic T cell lymphoma 1.5. Enteropathy-type T cell lymphoma without measurable disease 1.6. Blastic NK cell lymphoma 2. Intolerance of exogenous protein administration 3. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II - IV, appendix F) or left ventricular ejection fraction (LVEF) less than 45% 4. Significant renal dysfunction (serum creatinine greater than or equal to 150 µmol/l), unless related to NHL 5. Significant hepatic dysfunction (total bilirubin greater than or equal to 30 µmol/l or transaminases greater than or equal to 2.5 times normal level), unless related to NHL 6. Suspected or documented central nervous system involvement by NHL 7. Patients known to be human immunodeficiency virus (HIV)-positive 8. Patients with active, uncontrolled infections 9. Patients with uncontrolled asthma or allergy, requiring steroid treatment 10. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localised lymphoma mass or infiltration 11. History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR) including complete response uncertain (CRu) on protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Event-free survival, i.e., time from registration to induction failure (no CR, CRu or PR on induction treatment), death or relapse whichever occurs first; the time to failure of patients with induction failure is set at one day 2. Overall survival measured from the time of registration 3. Disease-free interval (duration of the first CR/CRu) measured from the time of achievement of CR to day of relapse or death from any cause (whichever occurs first) 4. Toxicity, Common Terminology Criteria for Adverse Events (CTCAE) grade 3 - 4, except nausea, vomiting, alopecia and haematological toxicity | — |
Countries
Netherlands
Outcome results
None listed