Diffuse large B-cell lymphoma
Conditions
Interventions
R-MEP therapy: rituximab (375mg/m2) on day1 iv, mitoxantrone (6mg/m2) on day2 iv, etoposide (80mg/m2) on day2-6 po and prednisolone (40mg/m2) on day2-6 po. The R-MEP is repeated every 3 weeks for tota
Sponsors
Clinical Hematology Study Group of National Hospital Organization (CHSG-NHO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) PS (ECOG) 0-2 2) Diffuse large B-cell lymphoma (WHO classification). Histologically/cytologically proven CD20 positive lymphoma 3) First relapse after prior chemotherapy. Interval of more than 24 weeks from the last chemotherapy 4) Having at least one measurable lesion 5) Well preserved major organ function 6) Cumulative doxorubicin doses <= 400mg/m2 7) Written informed consent 8) Expected survival of => 2 months
Exclusion criteria
Exclusion criteria: 1) CNS involvement 2) History of glaucoma 3) History of severe drug allergy 4) Active infectious diseases 5) HIV or HTLV-1 positive 6) HBs antigen or HCV antibody positive 7) Significant complications which include cardiac dysfunction, liver cirrhosis, uncontrolled diabetes, renal failure 8) Interstitial pneumonitis or fibrosis 9) History of other active malignancy 10) Severe mental disorder 11) Regular use of systemic steroids 12) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall tumor response | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response, three-year overall survival, three-year progression free survival, treatment related toxicity. | — |
Countries
Japan
Contacts
Public ContactTakuya Komeno
National Hospital Organization Mito Medical center Department of Hematology
Outcome results
None listed