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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)

Phase 2/Phase 3
20 Years
69 Years
Open (Enrolling)
Lymphoma, B-Cell

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Trial Information

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)

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

CR rate (phase II)

Outcome Time Frame:

during the study conduct

Safety Issue:


Principal Investigator

Kensei Tobinai, M.D.,Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Center Hospital


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

September 2002

Completion Date:

February 2010

Related Keywords:

  • Lymphoma, B-Cell
  • Rituximab
  • CHOP
  • Bi-weekly
  • low-grade B-cell lymphoma
  • advanced stage
  • follicular lymphoma
  • G-CSF
  • Untreated stage III/IV low-grade B-cell lymphoma
  • Lymphoma
  • Lymphoma, B-Cell