Diffuse large B-cell lymphoma
Conditions
Interventions
Arm A: 8 cycles of R-CHOP14 plus
G-CSF: pegfilgrastim (Neulasta)
Arm B 8 cycles of R-CHOP14 plus
G-CSF: pegfilgrastim (Neulasta) with intensification of rituximab (MabThera) during the first 4 cycl
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL) based upon a representative histology specimen according to the WHO classification 2. DLBCL must be CD20 positive 3. Ann Arbor stages II-IV 4. ≥ 66 and £ 80 years 5. Age WHO performance status 0 – 2 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Intolerance of exogenous protein administration 2. Severe cardiac dysfunction (NYHA classification III-IV or LVEF < 45%. Congestive heart failure or symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication. Myocardial infarction during the last 6 months 3. Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement 4. Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment 5. Significant hepatic dysfunction (total bilirubin ≥30mmol/l or transaminases ≥ 2.5 x upper normal limit), unless related to NHL 6. Significant renal dysfunction (serum creatinine ≥ 150 umol/l or clearance ≤ 60 ml/min), unless related to NHL 7. Clinical signs of severe cerebral dysfunction 8. Suspected or documented Central Nervous System involvement by NHL 9. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs 10. Testicular DLBCL 11. Primary mediastinal B cell lymphoma 12. Transformed indolent lymphoma 13. (EBV) post-transplant lymphoproliferative disorder 14. Secondary lymphoma after previous chemotherapy or radiotherapy 15. Major surgery, other than diagnostic surgery, within the last 4 weeks 16. Patients with active uncontrolled infections 17. Patients known to be HIV-positive 18. Active chronic hepatitis B or C infection 19. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease) 20. Life expectancy < 6 months 21. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (< 1 week) and/or cyclophosphamide (< 1 week and not in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms 22. 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 |
|---|---|
| First randomization: - Response rate (complete remission and FDG-PET negative partial remission or unconfirmed complete remission) Second randomization: - Failure free survival (measured from the date of second randomization) | — |
Secondary
| Measure | Time frame |
|---|---|
| First randomization: - Failure free survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive - Overall survival measured from the time of registration - Time to reach response - Toxicity Second randomization: - Overall survival - Toxicity | — |
Contacts
Public ContactP.J. Lugtenburg
Erasmus MC Afd. Hematologie Postbus 2040
Outcome results
None listed