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

Phase 2

Completed

• Conditions: Lymphoma, B-Cell
• Interventions: Drug: Rituximab + Standard CHOP; Drug: Rituximab + Bi-weekly CHOP

• 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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-05
• Study First Submitted QC: 2005-09-05
• Study First Posted: 2005-09-07
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• 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 Medical University; 🇯🇵 Aichi-gun,Nagakute,Yazako,Karimata,21, Aichi, 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 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

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 Cancer Center Hospital East; 🇯🇵 Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Ehime University Hospital; 🇯🇵 Shitsukawa,Toon, Ehime, Japan

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