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:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT00078533
Eligibility Criteria:
Inclusion criteria:
* Recipients of allogeneic donor stem cell transplants at risk for CMV reactivation with a CMV seropositive stem cell donor and at least 30 days post transplant.
* Recipients can have early evidence of CMV reactivation with greater than 2 leukocytes but less than 10 leukocytes positive for the CMV Ag per 100,000 cells.
* No evidence of graft-versus-host disease (GVHD) \> Grade II at time of enrollment.
* Life expectancy \> 30 days
* No severe intercurrent infections
* Lansky/Karnofsky scores greater than or equal to 60
* Absence of severe renal disease (Creatinine \> x 3 normal for age)
* Absence of severe hepatic disease (direct bilirubin \> 3 mg/dl or SGOT \> 500)
* Not receiving Ganciclovir, Foscarnet, or Cidofovir or other antiviral therapy for CMV reactivation
* Patient/guardian able to give informed consent
Exclusion Criteria:
* Patients with CMV negative stem cell donors
* Patients with GVHD Grades III-IV
* Patients receiving antiviral therapy for CMV reactivation or other viral infections such as adenovirus or herpes viruses
* Patients with significant CMV reactivation. Significant CMV reactivation is defined as one CMV Antigenemia reading with \>10 leukocytes positive for the CMV Ag per 100,000 cells
* 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
Study:
NCT00078533
Study Brief:
Protocol Section:
NCT00078533