131I-Rituximab consolidation in advanced diffuse large B-cell lymphoma
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 56
1. hitologically confirmed CD20 positive diffuse large B cell lymphoma
2. chemo-naive patient
3. no previous history of radiation therapy
4. no previous history of immunotherapy
5. measurable lesions?? ??? ??? ?? ?
6. =20 years old
7. Eastern Cooperative Oncology Group performance status = 2
8. adequate liver, kidney, bone marrow function
- serum creatinine=1.5 mg/dl or creatinine clearance =60 ml/min
- serum transaminases < 5 x upper normal limit
- serum bilirubin < 4 mg/dl
- neutrophil count=1,500/l, hemoglobin level=8 g/dl,
and platelets=100,000/l
9. more than 3 months of expected overall survival.
10. patient who agree the purpose and intention of this clinical trial
1. patients with involvement of cerebrospinal fluid
2. primary central nervous system lymphoma or diffuse large B cell lymphoma with central nervous system involvement
3. HIV positive
4. recent (<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)
5. hemodynamically unstable due to the recent (<12 months) history of severe heart disease such as myocardial infarction
6. acute complications of severe lung or metabolic disease
7. Combined severe neurological or psychiatric disease
8. Unrecovered from infection or other medical disease
9. Recent (<30 days) history of enrollment of other clinical trial
10. more than 25% of lymphoma marrow involvement
11. Previous history drug allergy to the content of 131I-rituximab
12. Pregnant or breast-feeding woman
13. women of childbearing potential and men not employing adequate contraception
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival
- Secondary Outcome Measures
Name Time Method overall survival