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

Japan Clinical Oncology Group

Status and phase

Terminated

Phase 3

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: Standard CHOP

Drug: Bi-CHOP (dose intensified CHOP)

Study type

Interventional

Funder types

Other

Identifiers

NCT00133302

C000000036

JCOG9809

Details and patient eligibility

About

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).

Full description

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).

Sex

All

Ages

15 to 69 years old

Volunteers

No Healthy Volunteers

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