Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)

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)

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

• Lymphoma
• Lymphoma, B-Cell

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

External Links

•   Link