A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma
Inclusion Criteria:
- Histologically confirmed follicular lymphoma or mantle cell lymphoma
- relapsed or refractory patients
- Eastern Cooperative Oncology Group performance status ≤ 2
- age≥ 20 years
- More than one measurable lesion (More than 2cm sized lesion in conventional CT
scan,More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT)
- Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min)
- Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal
limit)
- Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕)
- patient who agree the purpose and intention of this clinical trial
Exclusion Criteria:
- recent (<5 years) history of other malignancy or unrecovered from the disease
(appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)
- hemodynamically unstable due to the recent (<12 months) history of severe
- heart disease such as myocardial infarction
- acute complications of severe lung or metabolic disease
- Combined severe neurological or psychiatric disease
- Unrecovered from infection or other medical disease
- Recent (<30 days) history of enrollment of other clinical trial
- Pregnant or breast-feeding woman
- women of childbearing potential and men not employing adequate contraception at least
for 1 year
- previous history drug allergy to the content of 131I-rituximab
- Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier
can be enrolled)