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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00147121
Other study ID # JCOG0203
Secondary ID C000000033
Status Completed
Phase Phase 2/Phase 3
First received September 5, 2005
Last updated September 20, 2016
Start date September 2002
Est. completion date February 2010

Study information

Verified date September 2016
Source Japan Clinical Oncology Group
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma


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 information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab + Standard CHOP
Rituximab + Standard CHOP
Rituximab + Bi-weekly CHOP
Rituximab + Bi-weekly CHOP

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Haruhiko Fukuda Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

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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