臨床研究等提出・公開システム

JCOG0203: Rituximab + standard CHOP (R S-CHOP) vs Rituximab + bi-weekly CHOP (R Bi-CHOP) RCT(phase II/III) low-grade B-cell lymphoma at advanced stage (LowBNHL-RS/BiCHOP-P2/3)

JCOG0203: Rituximab + standard CHOP vs Rituximab + bi-weekly CHOP for untreated low-grade B-cell lymphoma at advanced stage (LowBNHL-RS/BiCHOP-P2/3)

300

Please find the "JCOG0203 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.

Please find the "JCOG0203 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.

Please find the "JCOG0203 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.

Please find the "JCOG0203 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.

R-CHOP was safe and efficacious without increasing fatal hematologic malignancies in the long-term and may, therefore, be a reasonable option as frontline therapy for advanced-stage FL.

Dec. 31, 2023

Sept. 19, 2011

https://ascopubs.org/doi/10.1200/JCO.2011.34.8508

No

-

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180257

NAGAI Hirokazu

National Hospital Organization Nagoya Medical Center

4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, 1, Japan

nagai.hirokazu.uf@mail.hosp.go.jp

NAKAYAMA Shinobu

National Hospital Organization Nagoya Medical Center

4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, 1, Japan

+81-52-951-1111

311-nmc-rec@mail.hosp.go.jp

Complete

Sept. 01, 2002

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1) Histological confirmed, low-grade B-cell lymphoma
(2) CD20-positive by flow cytometry or immunohistochemistry
(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) Having measurable leisions
(8) No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
(9) Normal BM, hepatic, renal, cardiac, and pulmonary function
(10) Written informed consent

(1) CNS involvement
(2) Glaucoma
(3) DM treated by insulin
(4) Uncontrolable HT
(5) AP, AMI, cardiomyopathy, arrhythmia
(6) Positive HBs antigen
(7) Seropositive to HCV
(8) Seropositive to HIV
(9) Interstitial pneumonitis, pulmonary fibrosis, or severe 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 for severe mental disease

Both

Untreated CD20-positive low-grade B-cell lymphoma at advanced stage

Arm A: Rituximab + Standard CHOP X 6 courses(every 3 weeks)
Rituximab 375 mg/m2 day1
Cyclophosphamide (CPA) 750 mg/m2(div) day 3
Doxorubicin(ADM) 50 mg/m2 (div) day 3
Vincristine (VCR)1.4 mg/m2 (iv) day 3
Prednisolone (PSL) 100 mg (po) day 3-7
Arm B: Rituximab + Bi-weekly CHOP X 6 courses (every 2 weeks)
Rituximab 375 mg/m2 day 1
Cyclophosphamide (CPA) 750 mg/m2 (div) day 3
Doxorubicin(ADM) 50 mg/m2 (div) day 3
Vincristine (VCR) 1.4 mg/m2 (iv) day 3
Prednisolone (PSL) day 3-7
G-CSF day 10-15

CR rate (phase II), PFS (phase III)

ORR, PFS, OS, Safety (phase II), OS, Safety (phase III)

+81-3-3542-2511

Nov. 21, 2018

none