untreated and advanced follicular lymphoma
Conditions
Interventions
The R-CHOP treatment 1 2 cycles 2 cycles of R-CHOP treatments are enforced as three-week one cycle. RituximubDay1375mg/m2/DayDiv Cyclophosphamids750mg/m2/dayDiv Doxorvicin50mg/m2/dayIv Vincristi
Sponsors
Department of Hematology and Rheumatology,Kinki University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Advance term (Ann Arbor stage III/IV) follicular lymphoma or stage II with a bulky disease of 7 cm or more (or 1.B cell non-Hodgkin's lymphoma, 2.Intermediate-high risk of FLIPI2 index 3.Treatment is required ) 2) Histologically confirmed CD20 positive B cell non-Hodgkin's lymphoma (follicular lymphoma: Grade 1-3a) 3) Mesureable disease (Major-axis:> 1.5 cm by CT) 4)age20-85 5)Performance Status (ECOG)0-2 6)Adequate organ function 7)No severe complications 8)Expected at least 3 months survival 9)Written informed consent obtained
Exclusion criteria
Exclusion criteria: 1)Any other active malignancies 2)Uncontrollable serious complications (diabetes, heart failure, cardiomyopathy, abnormal heart rhythm, angina, myocardial infarction, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, infection, a respiratory failure, an organic lung disease, hepatic insufficiency, liver cirrhosis, acute chronic hepatitis, renal insufficiency, etc.) patients with active tuberculosis 3)Circulating lymphoma cells >= 25,000 /uL in peripheral blood 4)Primary central nervous system lymphoma or central nervous system invasion 5)Anaphylactic shock for any drugs 6)The HCV antibody-positive 7)Inappropriate for rituximab treatment 8)Serious mental disorder, such as schizophrenia 9)Diagnosed as a malignant lymphoma, leukemia, and myelodysplastic syndromes in the past 10)The treatment history of the chemotherapy, the radiotherapy, cytokine therapy, and antibody therapy to FL 11)Pregnant/female patients who are unwilling to take prevention measures for contraception during treatment 12)HIV antibody-positive 13)Inappropriate for entry by physician's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival rate of 3 years of BR therapy enforcement group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Response rate 2) Complete response rate 3)Progression free survival (the median) 4) Safety (Adverse events) 5) Convalescence prediction factor of follicular lymphoma 6) Overall survival 7) histological transformation | — |
Countries
Japan
Contacts
Public Contactyouichi tatsumi
Kinki University Faculty of Medicine Department of Hematology and Rheumatology,
Outcome results
None listed