Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)
- Conditions
- Lymphoma, B-Cell
- Interventions
- Registration Number
- NCT00147121
- Lead Sponsor
- Haruhiko Fukuda
- 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 intervals of both rituximab and CHOP therapies using G-CSF, compared to the tri-weekly R-CHOP regimen.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Rituximab + Standard CHOP Rituximab+Standard CHOP 2 Rituximab + Bi-weekly CHOP Rituximab+bi-Weekly CHOP
- Primary Outcome Measures
Name Time Method CR rate (phase II) during the study conduct PFS (phase III) during the study conduct
- Secondary Outcome Measures
Name Time Method ORR, PFS, OS, Safety (phase II) during the study conduct OS, Safety (phase III) during the study conduct
Trial Locations
- Locations (45)
Aichi Cancer Center Hospital
🇯🇵Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Nagoya Daini Red Cross Hospital
🇯🇵Nagoya,Showa-ku,Myoken-cho,2-9, Aichi, Japan
Ehime University Hospital
🇯🇵Shitsukawa,Toon, Ehime, Japan
National Kyushu Cancer Center
🇯🇵Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan
University of Occupational and Environmental Health
🇯🇵Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1, Fukuoka, Japan
Mie University School of Medicine
🇯🇵Tsu,Edobashi,2-174, Mie, Japan
NHO Kumamoto Medical Center
🇯🇵Kumamoto,Ninomaru,1-5, Kumamoto, Japan
Kyoto Prefectural University of Medicine
🇯🇵Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465, Kyoto, Japan
Sasebo City General Hospital
🇯🇵Sasebo,Hirasemachi,9-3, Nagasaki, Japan
Oita Prefectural Hospital
🇯🇵Oita,Bunyo,476, Oita, Japan
Tokyo Metropolitan Komagome Hospital
🇯🇵Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan
Jikei University,Daisan Hospital
🇯🇵Komae,Izumihoncho,4-11-1, Tokyo, Japan
Aichi Medical University
🇯🇵Aichi-gun,Nagakute,Yazako,Karimata,21, Aichi, Japan
University of Fukui Hospital
🇯🇵Yoshida-gun,Matsuoka,Shimoaizuki,23-3, Fukui, Japan
School of Medicine,Fukuoka University
🇯🇵Fukuoka,Jonan-ku,Nanakuma,7-45-1, Fukuoka, Japan
Sapporo Hokuyu Hospital
🇯🇵Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1, Hokkaido, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
St.Marianna University School of Medicine,Yokohama City Seibu Hospital
🇯🇵Yokohama,Asahi-ku,Yasashi-cho,1197-1, Kanagawa, Japan
Tohoku University Hospital
🇯🇵Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Nagoya City University Hospital
🇯🇵Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1, Aichi, Japan
Nagoya University School of Medicine
🇯🇵Nagoya,Showa-ku, Tsurumai-cho,65, Aichi, Japan
Nagoya Medical Center
🇯🇵Nagoya,Naka-ku,Sannomaru,4-1-1, Aich, Japan
Akita University School of Medicine
🇯🇵Akita,Hondo,1-1-1, Akita, Japan
Chiba Cancer Center Hospital
🇯🇵Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan
National Hospital Organization Kyusyu Medical Center
🇯🇵FukuokaChuo-ku,Jigyohama,1-8-1, Fukuoka, Japan
Ohta Nishinouchi Hospital
🇯🇵Kohriyama,Nishinouchi,2-5-20, Fukushima, Japan
Gunma University
🇯🇵Maebashi,Showa,3-39-15, Gunma, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan
Imamura Bun-in Hospital
🇯🇵Kagoshima,Kamoikeshinmachi,11-23, Kagoshima, Japan
Kanazawa Medical University
🇯🇵Kahoku-gun,Uchinada-machi,Daigaku,1-1, Ishikawa, Japan
Kagoshima University,Faculty of Medicine
🇯🇵Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan
Tokai University School of Medicine
🇯🇵Isehara,Shimokasuya,143, Kanagawa, Japan
Kumamoto University Medical School
🇯🇵Kumamoto,Honjo,1-1-1, Kumamoto, Japan
Nagasaki Medical Center
🇯🇵Oomura,Kubara,2-1001-1, Nagasaki, Japan
Nagasaki University Hospital
🇯🇵Nagasaki,Sakamoto,1-7-1, Nagasaki, Japan
Faculty of Medicine,University of Ryukyus
🇯🇵Nakagami,Nishihara,Uehara,207, Okinawa, Japan
Faculty of Medicine, Saga University
🇯🇵Saga,Nabeshima,5-1-1, Saga, Japan
Shiga Medical Center for Adults
🇯🇵Moriyama,Moriyama,5-4-30, Shiga, Japan
Saitama Cancer Center
🇯🇵Kita-adachi,Ina,Komuro,818, Saitama, Japan
Kyorin University School of Medicine
🇯🇵Mitaka,Shinkawa,6-20-2, Tokyo, Japan
Hamamatsu University School of Medicine
🇯🇵Hamamatsu,Handayama,1-20-1, Shizuoka, Japan
National Cancer Center Hospital
🇯🇵Chuo-kum,Tsukiji, 5-1-1, Tokyo, Japan
Tokyo Medical University
🇯🇵Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan
Jikei University Hospital
🇯🇵Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan