low grade B cell lymphoma
Conditions
Interventions
The remission induction therapy with weekly 8 doses of rituximab(375mg/m2) followed by the 4 courses of every 6 months maintenance therapy with weekly 4 doses of rituximab(375mg/m2).
Sponsors
Clinical Hematology Study Group of National Hospital Organization(CHSG-NHO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.pathological diagnosis: low grade B cell lymphoma 2.CD20 antigen positive 3.Ann-Arbor stage: II-IV(without bulky lesion) 4.lymphoma cells less than 5000/mm3 in peripheral blood 5.presence of mesurable lesions 6.rituximab naive 7.hospitaized during first infusion of rituximab 8.PS(ECOG): 0-2 9.adequate organ funcitions 10.informed consented patients
Exclusion criteria
Exclusion criteria: 1.presence of central nervous invasion(clinical or pathological). 2.transformed patients (clinical or pathological). 3.past history of glaucoma. 4.past history of severe drug allergy. 5.HIV Ab positive or HTLV-1 Ab positive. 6.HBsAg positive, HBsAb positive, or HCV Ab positive. 7.severe cardiac disease 8.hepatic cirrhosis 9.uncontrollable diabetis melitus 10.patients with dialysis 11.lung fibrosis or interstitial pneumonitis 12.other active malignancies 13.pregnant or feeding female 14.severe mental disorder 15.systemic therapy with corticosteroid 16.judged for inappropriate with other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate, 3 years over all survival, safety, 3 years progression free survival | — |
Countries
Japan
Contacts
Public ContactHIROKAZU NAGAI
National Hospital Organization Nagoya Medical Center Clinical Research Center
Outcome results
None listed