Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

• Status: Terminated
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to investigate the clinical benefit of the dose intensified regimen, Bi-CHOP in comparison to standard CHOP for advanced intermediate or high grade non-Hodgkin's lymphoma (NHL).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Oncology Group
• Collaborator: Ministry of Health, Labour and Welfare, Japan

Criteria

Inclusion Criteria:

• Intermediate- or high-grade non-Hodgkin's lymphoma, excluding cutaneous t-cell lymphoma (CTCL), adult T-cell leukemia-lymphoma (ATL) and T-cell lymphoblastic lymphoma (T-LbL) (Working Formulation)

• Ann Arbor stage: II, III, IV

• No prior chemotherapy or radiotherapy

• Age: 15 to 69

• Performance status (PS): 0, 1, 2

• WBC >= 3,000 /mm3, ANC >= 1,200 /mm3, Platelet >= 75,000 /mm3

• GOT/GPT <= 5 x Normal Upper Limit, T-Bil <= 2.0 mg/dL

• Creatinine <= 2.0 mg/dL

• Normal ECG, Ejection Fraction >= 50%

• PaO2 >= 65 mmHg

• Written informed consent

Exclusion Criteria:

• Uncontrollable diabetes mellitus

• Severe complication (infection, heart failure, renal failure, liver failure, etc)

• Anamnesis of heart disease

• Acute or chronic hepatitis, liver cirrhosis and portal hypertension

• Synchronous or metachronous malignancy

• Severe pulmonary dysfunction

• Central nervous system (CNS) invasion

• HIV positive

• Hepatitis B surface antigen (HBs-Ag) positive

• Hepatitis C virus antibody (HCV-Ab) positive