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)

Completed

• Conditions: CD20 positive diffuse large B cell lmyphoma

• Registration Number: jRCTs031180139

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-10
• Study First Submitted: 2019-02-20
• Last Update Posted: 2023-12-09

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 422

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		phase II: complete response rate; phase III: progression free survival