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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT00673868
Eligibility Criteria:
Inclusion Criteria:
* Any allogeneic stem cell transplant recipient \> 2 years of age who is CMV sero-positive and has a CMV sero-positive donor,
* Bilirubin \< 2.0 mg/dl; SGOT/SGPT \< 2.5 X normal.
* Creatinine clearance \> 50 cc/min as estimated by patient's serum creatinine, weight, and age.
* Pulse oximetry \> 95% on no supplemental oxygen.
* ECOG performance status \< 2; for patients, 16 years of age, Lansky performance status \>70%.
Exclusion Criteria:
* Sero-negative patients with a history of GVHD of grade II or greater by the Glucksberg crireria (protocol Appendix I) at or prior to day +30 of current stem cell transplant are excluded.
* Patients who have received a prior stem cell transplant are excluded.
* Patients who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month.
* Subjects receiving systemic immunosuppressive agents for the treatment of GVHD at the time of the CTL infusion will be excluded from receiving CTL, and subjects randomized to not receive CTL will also be removed from study if at the time of the CTL infusion they require systemic immunosuppression for treatment of GVHD
* Donors must be negative for HIV-1, HIV-2, and HTLV-2, and have passed all screening tests for hepatitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
65 Years
Study:
NCT00673868
Study Brief:
Protocol Section:
NCT00673868