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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02982902
Eligibility Criteria:
Inclusion Criteria:
* Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
* Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)
* Patients may have asymptomatic viremia (\>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND
* Patients must have ONE OF THE NEXT FOUR CRITERIA:
* Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or
* New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or
* Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.
* Second recurrence of CMV viremia, CMV-related symptoms, signs and/or markers of end organ compromise.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
* Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.
Exclusion Criteria:
* Pregnant or breastfeeding women are excluded from this study.
* Patients with opportunistic viral infections other than CMV.
* Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (\>0.5 mg/kg/day prednisone or its equivalent) as treatment
* Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.
* Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.
Donor eligibility
* Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this).
* Must have evidence of a serologic response (i.e. be seropositive) against CMV.
* Age ≥ 18 years
* Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program
* Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Study:
NCT02982902
Study Brief:
Protocol Section:
NCT02982902