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

H

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

Trial contacts and locations

45

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Data sourced from clinicaltrials.gov

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