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

Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

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).

The purpose of JCOG9809 was to determine whether treatment results of aggressive NHL could be improved by shortening intervals of CHOP chemotherapy with the prophylactic use of G-CSF. The primary endpoint was Progression Free Survival (PFS), and the planned accrual was 450. Until December, 2002, 323 patients with advanced aggressive NHL were randomized to standard CHOP arm (CHOP x 8, every three weeks) and biweekly CHOP arm (CHOP x 8, every two weeks).

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