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 @ 2:27 PM
Ignite Modification Date:
2025-12-24 @ 2:27 PM
NCT ID:
NCT00043459
Eligibility Criteria:
Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL)
* Subjects must have received prior chemotherapy for their NHL
* At least 18 years of age
* Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
* Karnofsky performance status of at least 70%
* Estimated life expectancy of at least 12 weeks
* Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
* Subject must be able to comply with study procedures and follow-up examinations.
* Signed written informed consent
* Lab Values (obtained ≤ 7 days prior to study enrollment):
* ANC at least 1.5x10e9/L,
* Platelet count at least 100x10e9/L,
* Hemoglobin at least 8.5 g/dL,
* Creatinine within 2 times upper limit of normal,
* AST and ALT within 3 times upper limit of normal,
* Bilirubin within 1.5 times upper limit of normal,
* Albumin great than 2.5 g/dL,
Exclusion Criteria
* Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
* NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of \<50%, or acute anginal symptoms
* Patients who have received any investigational agent within 4 weeks of enrollment
* Patients who are pregnant or breast-feeding
* History of prior malignancy other than NHL within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* History of central nervous system metastases or carcinomatous meningitis
* Major surgery within 4 weeks of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00043459
Study Brief:
Protocol Section:
NCT00043459