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 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT01536561
Eligibility Criteria:
Inclusion Criteria
* Subjects had histologically-confirmed NHL.
* Subjects with low-, intermediate-, or high-grade histologies, according to the International Working Formulation.
* Subjects had relapsed after or had failed to respond to at least 1 prior chemotherapy regimen.
* Subjects had evidence that their tumor tissue expressed the CD20 antigen.
Exclusion Criteria
* ≥25% bone marrow involvement.
* Absolute granulocyte count ≥1500 cells/mm3 or platelet count ≤100,000 platelets/mm3.
* Creatinine ≥2.0 mg/dL, bilirubin ≥2.0 mg/dL.
* Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks of study entry.
* Active infection, collagen vascular disease, vasculitis, glomerulonephritis, New York Heart Association class II or IV heart disease and/or serious illness.
* Prior external beam radiation therapy such that the maximum tolerated dose level for any normal organ would be exceeded by additional irradiation.
* Pregnancy.
* Allergy to iodine or previous sensitization to mouse protein as documented by positive anti-mouse antibody ELISA test.
* Known brain metastases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01536561
Study Brief:
Protocol Section:
NCT01536561