None listed
Conditions
Interventions
Patients will be randomized between:
- Arm A: 6 cycles of rituximab-iCHOP q 2 weeks plus G-CSF:
pegfilgrastim (Neulasta®)
- Arm B: 3 cycles of rituximab-iCHOP q 2 weeks plus G-CSF:
pegfilgrastim (Neul
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification; 2. Ann Arbor stage II-IV; 3. High-intermediate or high risk NHL according to age-adjusted IPI score (aa IPI=2-3); 4. DLBCL must be CD20 positive; 5. Age 18-65 years inclusive; 6. WHO performance status <= 2; 7. Negative pregnancy test (if applicable); 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Intolerance of exogenous protein administration; 2. Severe cardiac dysfunction (NYHA classification II-IV, Appendix F) or LVEF = 150 mumol/l), unless related to NHL; 4. Significant hepatic dysfunction (total bilirubin >= 30 mumol/l or transaminases >= 2.5 times normal level), unless related to NHL; 5. Suspected or documented Central Nervous System involvement by NHL; 6. Testicular DLBCL; 7. Primary mediastinal B cell lymphoma; 8. Patients known to be HIV-positive; 9. Patients with active, uncontrolled infections; 10. Patients with uncontrolled asthma or allergy, requiring steroid treatment; 11. Patient is a lactating woman; 12. Unwillingness or not capable to use effective means of anticonception (all men and pre-menopausal women); 13. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (< 1 wk) and/or cyclophosphamide (< 1 wk and not in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms; 14. 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 |
|---|---|
| Event-free survival (i.e. time from registration to induction failure (i.e. less than PR after 3 x R-iCHOP, no CR (CRu) after 6 RiCHOP (arm A) or ASCT (arm B), death, progression or relapse whichever occurs first); the time to failure of patients with induction failure (less than PR after 3 x R-iCHOP) is set at one day. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete response (including CRu); 2. Progression on protocol (progression or relapse after initial PR or CR during protocol treatment); 3. Overall survival measured form the time of registration; 4. Disease-free interval (duration of the first CR) measured from the time of achievement of CR (including CRu) after protocol treatment to day of relapse or death from any cause (whichever occurs first). | — |
Contacts
Public ContactG.W. Imhoff, van
University Medical Center Groningen (UMCG), Department of Hematology P.O. Box 30001
Outcome results
None listed