Status:
COMPLETED
Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
20-69 years
Phase:
PHASE2
PHASE3
Brief Summary
To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma
Detailed Description
Since currently there is no standard therapy for untreated advanced-stage low-grade B-cell lymphoma, Phase 2/3 study was planned. Comparison(s): An intensified bi-weekly version by shortening the inte...
Eligibility Criteria
Inclusion
- Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL
- CD20-positive
- Ann Arbor CS III or IV
- Lymphoma cell count in PB≦10,000/mm3
- 20\<=age\<=69
- ECOG PS 0-2
- Bidimensionally measurable disease \>1.5cm in a single dimension by CT scans
- No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
- Normal BM, hepatic, renal, cardiac, and pulmonary function
- Written informed consent
Exclusion
- CNS involvement
- Glaucoma
- DM treated by insulin
- Uncontrollable HT
- AP, AMI
- Positive HBs antigen
- seropositive to HCV
- seropositive to HIV
- Interstitial pneumonitis, pulmonary fibrosis, or emphysema
- Severe infection
- Liver cirrhosis
- Double cancer
- Pregnant or lactating
- Patients who desire auto PBST after CR
- Patients treated with major tranquilizer or antidepressant
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00147121
Start Date
September 1 2002
End Date
February 1 2010
Last Update
September 22 2016
Active Locations (45)
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1
Aichi Medical University
Aichi-gun,Nagakute,Yazako,Karimata,21, Aichi-ken, Japan, 480-1195
2
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
3
Nagoya City University Hospital
Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1, Aichi-ken, Japan, 467-8601
4
Nagoya University School of Medicine
Nagoya,Showa-ku, Tsurumai-cho,65, Aichi-ken, Japan, 466-8550