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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000929

Enrollment

422

Registered

2007-12-04

Start date

2007-12-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CD20 positive diffuse large B cell lmyphoma

Interventions

A:R-CHOP B:RW+CHOP(weekly rituximab plus CHOP)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)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 (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 10000/mm3 (6)Performance Status: 0-2 (7)no CNS invasion (8)having measurable lesion (9)no prior chemotherapy, radiotherapy and anti-body therapy (10)WBC: more than 3000/mm3 (11)neutrophil: more than 1000/mm3 (12)platlets: more than 10x104/mm3 (13)AST: no more than 150 U/L (14)ALT: male: no more than 210 U/L female: no more than 115 U/L (15)T-bil: no more than 2.0mg/dl (16)creatinine: no more than 2.0mg/dl (17)normal ECG (18)ejection fraction: more than 50% (19)PaO2: more than 65mmHg(room air) (20)written informed consent

Exclusion criteria

Exclusion criteria: (1)anamnesis of graucoma (2)diabetes mellitus treating insulin or uncontrolled (3)uncontrollable hypertension (4)coronary artery necessary, cardiomyopathy and heart failure necessary treatment, arrhythmia treating antiarrhyshmic (5)HBs-Ag positive (6)HCV positive (7)HIV positive (8)interstitial pneumonia, plumonary fiblosis (9)severe infection (10)synchronous or metachronous malignancy (11)pregnant/lactating woman (12)psychosis (13)given systemic steroid

Design outcomes

Primary

Measure	Time frame
phaseII : complete response rate phaseIII : progression free survival	—

Secondary

Measure	Time frame
phaseII : progression free survival, overall survival, adverse events, seriouse adverse events phaseIII : overall survival, adverse events, seriouse adverse events	—

Countries

Japan

Contacts

Public ContactKen Ohmachi

JCOG0601 Coordinating Office Tokai University, Division of Hematology Oncology

JCOG_sir@ml.jcog.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026