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

Haruhiko Fukuda

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lymphoma, B-Cell

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00147121

JCOG0203

C000000033

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

1

Active Comparator group

Description:

Rituximab+Standard CHOP

Treatment:

Drug: Rituximab + Standard CHOP

2

Experimental group

Description:

Rituximab+bi-Weekly CHOP

Treatment:

Drug: Rituximab + Bi-weekly CHOP