KCT0000526
Recruiting
未知
An investigator intitiated clnical trial for evaluating the efficacy and safety of 131I-Rituximab treatment as consolidation in the patients with CD20 positive advanced diffuse large B-cell lymphoma after standard combination chemotherapy
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Korea Institute of Radiological & Medical Sciences
- Enrollment
- 56
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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