Phase 2 Study of Abbreviated 3 Cycles of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised Stage I or II CD20+ Diffuse Large B-cell Lymphoma
Inclusion Criteria:
- Patients who underwent curative resection of primary tumor
- Pathologically confirmed CD20 positive diffuse large B-cell lymphoma (DLBCL) after
surgical resection
- Ann Arbor Stage I or II
- No history of chemotherapy
- Performance status: ECOG 0-2
- Age: 18 to 70 years old
- Complete excision with negative resection margin on pathologic report after surgery
- Cardiac ejection fraction ≥ 50% as measured by MUGA or 2D echocardiography without
clinically significant abnormalities
- Adequate renal function: serum creatinine level below 2 mg/dL (177μmol/L)
- Adequate liver functions: Transaminase (AST/ALT) < 3X upper normal value, Bilirubin <
2X upper normal value
- Adequate hematologic function: hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥
1,500/mm3 and platelet count ≥ 75,000/mm3
- Informed consent
Exclusion Criteria:
- Patients with a known history of HIV (+) or HCV (+). However, HBV(+) patients are
eligible if primary prophylaxis is given
- Previous or concurrent cancer that is distinct in primary site or histology from
DLBCL, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial
bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to
entry is permitted
- Pregnant or lactating women, women of childbearing potential not employing adequate
contraception
- Other serious illness or medical conditions
1. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia symptomatic
coronary artery disease) despite treatment, myocardial infarction within 6
months prior to study entry
2. History of significant neurological or psychiatric disorders including dementia
or seizures
3. Active uncontrolled infection (viral, bacterial or fungal infection)
4. Other serious medical illnesses
- Known hypersensitivity to any of the study drugs or their ingredients
- Concomitant administration of any other experimental drug under investigation, or
concomitant chemotherapy, hormonal therapy, or immunotherapy
- Patient with B symptoms or Bulky disease