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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT01923766
Eligibility Criteria:
Inclusion criteria at the time of Procurement:
* Patient with malignant or nonmalignant diseases who are candidates for transplant.
* Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens.
Inclusion criteria at the time of CTL infusion:
* Recipients of at least one unmanipulated cord blood unit fractionated into 2 fractions (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV/Adenoviral disease or reactivation.
* Lansky/Karnofsky scores \>60
* Absolute neutrophil count (ANC) greater than 500/ul.
* No evidence of GVHD \> Grade II at time of enrollment.
* Life expectancy \> 30 days
* Absence of severe renal disease (Creatinine \> x 3 normal for age)
* Absence of severe hepatic disease. Direct bilirubin must be \< 3 mg/dl and AST \< 5x upper limit of normal.
* Patient must be at least 30 days post transplant to be eligible to receive CTL
* Written informed consent and/or signed assent line from patient, parent or guardian.
* Patient not on Fi02 of \>60%
Exclusion criteria at the time of Procurement
* Pregnant or lactating
* Patients with active central nervous system disease
* Patients with Karnofsky performance status \<70%
* Patients with grade 3 or 4 or primary myelofibrosis
* Patients with suitable related donors
Exclusion criteria at the time of CTL infusion
* Pregnant or lactating
* Unable to wean steroids to ≤0.5 mg/kg/day prednisone.
* Patients with other uncontrolled infections (except CMV and/or adenovirus and/or EBVemia).
* Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Weeks
Study:
NCT01923766
Study Brief:
Protocol Section:
NCT01923766