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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00058604
Eligibility Criteria:
Inclusion Criteria:
* Patients falling into one of the following categories:
* Organ transplant recipients at high risk of developing LPD:
* EBV seronegative recipients
* Organ transplant recipients receiving OKT3 for immunosuppression
* Organ transplant recipients with evidence of LPD
* Organ transplant recipients with EBV DNA level \>1,000 copies
* Age \<70 yrs old
* Signed informed consent obtained from patient/guardian
* CTLs available
* Performance status; ECOG £ 2
* Creatinine \< 3X normal
* Bilirubin \< 5X normal
* AST \< 5X normal
* Has not received any other investigational cellular therapies within the past 30 days.
Exclusion criteria:
* Patients with a severe intercurrent infection
* Patients with life expectancy of less than 6 weeks
* Patients receiving supplemental oxygen.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
70 Years
Study:
NCT00058604
Study Brief:
Protocol Section:
NCT00058604