Lymphoma, B-Cell Clinical Trial
Official title:
Rituximab + Standard CHOP (R・S-CHOP) vs Rituximab+ Bi-weekly CHOP (R・Bi-CHOP) RCT(Phase II/III) for Stage III/IV Low-grade B-cell Lymphoma (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203)
To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma
Status | Completed |
Enrollment | 300 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 69 Years |
Eligibility |
Inclusion Criteria: 1. Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL 2. CD20-positive 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. Bidimensionally measurable disease >1.5cm in a single dimension by CT scans 8. No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy 9. Normal BM, hepatic, renal, cardiac, and pulmonary function 10. Written informed consent Exclusion Criteria: 1. CNS involvement 2. Glaucoma 3. DM treated by insulin 4. Uncontrollable HT 5. AP, AMI 6. Positive HBs antigen 7. seropositive to HCV 8. seropositive to HIV 9. Interstitial pneumonitis, pulmonary fibrosis, or 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Aichi Medical University | Aichi-gun,Nagakute,Yazako,Karimata,21 | Aichi |
Japan | Akita University School of Medicine | Akita,Hondo,1-1-1 | Akita |
Japan | Tokyo Metropolitan Komagome Hospital | Bunkyo-ku,Honkomagome,3-18-22 | Tokyo |
Japan | Chiba Cancer Center Hospital | Chiba,Chuo-ku,Nitona-cho,666-2 | Chiba |
Japan | National Cancer Center Hospital | Chuo-kum,Tsukiji, 5-1-1 | Tokyo |
Japan | School of Medicine,Fukuoka University | Fukuoka,Jonan-ku,Nanakuma,7-45-1 | Fukuoka |
Japan | National Kyushu Cancer Center | Fukuoka,Minami-ku,Notame,3-1-1 | Fukuoka |
Japan | National Hospital Organization Kyusyu Medical Center | FukuokaChuo-ku,Jigyohama,1-8-1 | Fukuoka |
Japan | Hamamatsu University School of Medicine | Hamamatsu,Handayama,1-20-1 | Shizuoka |
Japan | Tokai University School of Medicine | Isehara,Shimokasuya,143 | Kanagawa |
Japan | Imamura Bun-in Hospital | Kagoshima,Kamoikeshinmachi,11-23 | Kagoshima |
Japan | Kagoshima University,Faculty of Medicine | Kagoshima,Sakuragaoka,8-35-1 | Kagoshima |
Japan | Kanazawa Medical University | Kahoku-gun,Uchinada-machi,Daigaku,1-1 | Ishikawa |
Japan | National Cancer Center Hospital East | Kashiwa,Kashiwanoha,6-5-1 | Chiba |
Japan | Saitama Cancer Center | Kita-adachi,Ina,Komuro,818 | Saitama |
Japan | University of Occupational and Environmental Health | Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1 | Fukuoka |
Japan | Ohta Nishinouchi Hospital | Kohriyama,Nishinouchi,2-5-20 | Fukushima |
Japan | Jikei University,Daisan Hospital | Komae,Izumihoncho,4-11-1 | Tokyo |
Japan | Kumamoto University Medical School | Kumamoto,Honjo,1-1-1 | Kumamoto |
Japan | NHO Kumamoto Medical Center | Kumamoto,Ninomaru,1-5 | Kumamoto |
Japan | Kyoto Prefectural University of Medicine | Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465 | Kyoto |
Japan | Gunma University | Maebashi,Showa,3-39-15 | Gunma |
Japan | Jikei University Hospital | Minato-ku,Nishishinbashi,3-25-8 | Tokyo |
Japan | Kyorin University School of Medicine | Mitaka,Shinkawa,6-20-2 | Tokyo |
Japan | Shiga Medical Center for Adults | Moriyama,Moriyama,5-4-30 | Shiga |
Japan | Nagasaki University Hospital | Nagasaki,Sakamoto,1-7-1 | Nagasaki |
Japan | Aichi Cancer Center Hospital | Nagoya,Chikusa-ku,Kanokoden,1-1 | Aichi |
Japan | Nagoya City University Hospital | Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1 | Aichi |
Japan | Nagoya Medical Center | Nagoya,Naka-ku,Sannomaru,4-1-1 | Aich |
Japan | Nagoya University School of Medicine | Nagoya,Showa-ku, Tsurumai-cho,65 | Aichi |
Japan | Nagoya Daini Red Cross Hospital | Nagoya,Showa-ku,Myoken-cho,2-9 | Aichi |
Japan | Faculty of Medicine,University of Ryukyus | Nakagami,Nishihara,Uehara,207 | Okinawa |
Japan | Niigata Cancer Center Hospital | Niigata,Kawagishi-cho,2-15-3 | Niigata |
Japan | Oita Prefectural Hospital | Oita,Bunyo,476 | Oita |
Japan | Nagasaki Medical Center | Oomura,Kubara,2-1001-1 | Nagasaki |
Japan | Faculty of Medicine, Saga University | Saga,Nabeshima,5-1-1 | Saga |
Japan | Sapporo Hokuyu Hospital | Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1 | Hokkaido |
Japan | National Hospital Organization Hokkaido Cancer Center | Sapporo,Shiroishi-ku,Kikusui,4-2-3-54 | Hokkaido |
Japan | Sasebo City General Hospital | Sasebo,Hirasemachi,9-3 | Nagasaki |
Japan | Tohoku University Hospital | Sendai,Aoba-ku,Seiryo-machi,1-1 | Miyagi |
Japan | Tokyo Medical University | Shinjuku-ku,Nishi-shinjuku,6-7-1 | Tokyo |
Japan | Ehime University Hospital | Shitsukawa,Toon | Ehime |
Japan | Mie University School of Medicine | Tsu,Edobashi,2-174 | Mie |
Japan | St.Marianna University School of Medicine,Yokohama City Seibu Hospital | Yokohama,Asahi-ku,Yasashi-cho,1197-1 | Kanagawa |
Japan | University of Fukui Hospital | Yoshida-gun,Matsuoka,Shimoaizuki,23-3 | Fukui |
Lead Sponsor | Collaborator |
---|---|
Haruhiko Fukuda | Ministry of Health, Labour and Welfare, Japan |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CR rate (phase II) | during the study conduct | No | |
Primary | PFS (phase III) | during the study conduct | No | |
Secondary | ORR, PFS, OS, Safety (phase II) | during the study conduct | Yes | |
Secondary | OS, Safety (phase III) | during the study conduct | Yes |
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