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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT02988258
Eligibility Criteria:
Patient Inclusion Criteria:
* Undergoing matched sibling allogeneic HSCT for an underlying haematological malignancy with a CMV seronegative donor
* Age ≥ 18 years and ≤ 65 years
* HLA-A\*0201 positive
* CMV seropositive (CMV IgG detected) pre-transplant
* Informed consent in writing and ability to co-operate with treatment and follow up.
* Prepared to undergo additional study procedures as per study schedule
* Patient has undergone counselling about risk
* Serologically negative for HIV 1\&2, Hep B, Hep C and syphilis
* Female patients of child-bearing age must have a negative pregnancy test and agree to use reliable contraceptive methods for the duration of the therapy and for 6 months afterwards
* Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards
And to be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release):
* Donor engraftment (neutrophils \> 0.5x109/l).
* Single positive CMV PCR result (\> 200 copies/ml)
Patient Exclusion Criteria:
* Pregnant or lactating women
* Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
* HIV infection
And to be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release):
* Active acute GVHD \> Grade I
* Concurrent use of systemic corticosteroids
* Organ dysfunction as measured by
* creatinine \> 200 uM/l
* bilirubin \> 50 uM/l
* ALT \> 3x upper limit of normal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02988258
Study Brief:
Protocol Section:
NCT02988258