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JCOG0601: Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (NHL-R-CHOP-P2/3)

JCOG0601: Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (NHL-R-CHOP-P2/3)

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Please find the "JCOG0601 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 "JCOG0601 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 "JCOG0601 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 "JCOG0601 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.

In combination of standard CHOP and rituximab, dose-dense weekly rituximab at early phase of treatment did not improve the PFS in patients with untreated DLBCL.

Dec. 09, 2023

Feb. 16, 2021

https://ashpublications.org/bloodadvances/article/5/4/984/475201/A-randomized-phase-2-3-study-of-R-CHOP-vs-CHOP

No

-

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180139

ANDO Kiyoshi

Tokai University Hospital

143, Shimokasuya, Isehara, Kanagawa, 259-1193

andok@keyaki.cc.u-tokai.ac.jp

OHMACHI Ken

Tokai University Hospital

142, Shimokasuya, Isehara, Kanagawa, 259-1193

+81-463-93-1121

8jmmd004@is.icc.u-tokai.ac.jp

Complete

Dec. 04, 2007

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Histologically proven CD20 positive diffuse large B-cell lymphoma (WHO classification), excluding histological transformation form marginal zone B cell lymphoma or follicular lymphoma and immunodeficiency associated lymphoproliferative disorders.
2) lymphoma with CD20 positive by immunohistochemistry or flow cytometry of biopsy epecimen or surgical specimen
3) clinical staging is evaluated by diagnostic imaging procedures within 28 days before entry.
4) stage I disease without bulky mass inappropriate for chemo-radiotherapy
5) lymphoma cells in peripheral blood: no more than 10,000 /mm3
6) ECOG Performance Status: 0-2
7) no clinical 0CNS invasion
8) having measurable lesion
9) no prior chemotherapy, radiotherapy and anti-body therapy
10) sufficient organ function
i) WBC: more than 3000 /mm3
ii) Neutrophil: more than 1000 /mm3
iii) Platlets: more than 10x104 /mm3
iv) AST: no more than 150 U/L
v) male ALT: no more than 210 U/L, female: ALT: no more than 115 U/L
vi) T-bil: no more than 2.0mg/dl
vii) Creatinine: no more than 2.0mg/dl
viii) normal ECG without ischemic change, atrial fibrillation, and ventricular arrhythmia
ix) ejection fraction: more than 50% by echocardiogram
x) PaO2: more than 65mmHg (room air)
11) written informed consent

1) Anamnesis of glaucoma
2) Diabetes mellitus under treatment with insulin or uncontrolled
3) Uncontrollable hypertension
4) Coronary artery disorder, cardiomyopathy and heart failure requiring treatment, antiarrhyshmic treated arrhythmia
5) HBs antigen positive
6) HCV antibody positive
7) HIV antibody positive
8) Interstitial pneumonia, or plumonary fiblosis
9) Severe infection
10) Synchronous or metachronous active malignancy. With a history of malignant lymphoma, myelodysplastic syndrome, or leukemia during complete remission
11) Interstitial pneumonia, fibroid lung, or severe emphysema
12) psychosis or psychiatric symptoms are judged not to be able to participate in this clinical study
13) given systemic steroid

Both

CD20 positive diffuse large B cell lmyphoma

A: R-CHOP (tri-weekly rituximab plus CHOP), 8 cycles
Cyclophosphamide 750 mg/m2, day 1
Doxorubicin 50 mg/m2, day 1
Vincristine 1.4 mg/m2 (max 2.0 mg/body), day 1
Prednisolone 100 mg/body, day 1-5
Rituximab 375 mg/m2, day 1
B: RW+CHOP (weekly rituximab plus CHOP) , 8 cycles
Cyclophosphamide 750 mg/m2, day 1
Doxorubicin 50 mg/m2, day 1
Vincristine 1.4 mg/m2 (max 2.0 mg/body), day 1
Prednisolone 100 mg/body, day 1-5
Rituximab 375 mg/m2, day 1,8,15,22,29,36,43,50

phase II: complete response rate
phase III: progression free survival

phase II: progression free survival, overall survival, adverse events, seriouse adverse events
phaseIII: overall survival, adverse events, seriouse adverse events

+81-3-3542-2511

Nov. 29, 2018

none