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 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT00521261
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed CD20-positive non-Hodgkin lymphoma
* Relapsed, resistant, or chemorefractory disease
* Must have an available HLA-identical sibling donor
* No significant skin breakdown from tumor or other disease
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* DLCO ≥ 50% of normal
* No symptomatic obstructive or restrictive pulmonary disease
* Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
* Direct bilirubin ≤ 2.0 mg/dL (even if attributable to disease)
* SGOT and SGPT ≤ 2.5 times normal (even if attributable to disease)
* No history of severe hepatic dysfunction
* No severe cardiac dysfunction
* LVEF ≥ 50% by gated blood pool scan
* No major heart disease
* Patients with congenital or acquired heart disease or cardiac arrhythmias must undergo a cardiology consultation and evaluation
* No active infections
* Patients who have not been seen and evaluated by a dentist for teeth cleaning and examination for potential sources of infection are ineligible
* HIV antibody negative
* No uncompensated major thyroid or adrenal dysfunction
* Not pregnant or nursing
* Persistently elevated systolic blood pressure (BP) ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg must be controlled with antihypertensive agents for at least 7 days prior to initiation of cell therapy
* Patients with essential hypertension that is controlled with medication are eligible
PRIOR CONCURRENT THERAPY:
* Prior total dose of doxorubicin or daunorubicin must have been less than 450 mg/m\^2 unless an endomyocardial biopsy shows less than grade 2 drug effect
* No concurrent nitroglycerin preparations for angina pectoris
* No antiarrhythmic drugs for major ventricular dysrhythmias
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00521261
Study Brief:
Protocol Section:
NCT00521261