JCOG0203: Rituximab + standard CHOP vs Rituximab + bi-weekly CHOP for untreated low-grade B-cell lymphoma at advanced stage
- Conditions
- ntreated CD20-positive low-grade B-cell lymphoma at advanced stage
- Registration Number
- JPRN-jRCTs031180257
- Lead Sponsor
- AGAI Hirokazu
- Brief Summary
R-CHOP was safe and efficacious without increasing fatal hematologic malignancies in the long-term and may, therefore, be a reasonable option as frontline therapy for advanced-stage FL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 300
(1) Histological confirmed, low-grade B-cell lymphoma
(2) CD20-positive by flow cytometry or immunohistochemistry
(3) Ann Arbor CS III or IV
(4) Lymphoma cell count in PB<=10,000/mm3
(5) 20<=age<=69
(6) ECOG PS 0-2
(7) Having measurable leisions
(8) No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
(9) Normal BM, hepatic, renal, cardiac, and pulmonary function
(10) Written informed consent
(1) CNS involvement
(2) Glaucoma
(3) DM treated by insulin
(4) Uncontrolable HT
(5) AP, AMI, cardiomyopathy, arrhythmia
(6) Positive HBs antigen
(7) Seropositive to HCV
(8) Seropositive to HIV
(9) Interstitial pneumonitis, pulmonary fibrosis, or severe emphysema
(10) Severe infection
(11) Liver cirrhosis
(12) Double cancer
(13) Pregnant or lactating
(14) Patients who desire auto PBST after CR
(15) Patients treated with major tranquilizer or antidepressant for severe mental disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method