Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT01678404
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed marginal zone B-cell lymphoma
* relapsed or refractory patients after treatment including chemotherapy, radiation therapy, and surgery
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01678404
Study Brief:
Protocol Section:
NCT01678404