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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT01220895
Eligibility Criteria:
Inclusion Criteria:
1. Age 16 years or older
2. cytomegalovirus seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) hematopoietic stem cell transplant recipient with cytomegalovirus (CMV) seropositive unrelated donor
3. Patient Informed consent
1. Prepared to undergo additional study procedures as per study schedule
2. Patient has undergone counselling about risk
4. Donor engraftment (neutrophils \> 0.5x109/l)(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)
5. Single positive cytomegalovirus PCR result (And to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion)
6. The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure.
7. Donor must have met requirements of EU Tissue and Cells Directive(2004/23/EC) as amended and the UK statutory instruments pursuant therein.
8. Healthy, Cytomegalovirus (CMV)seropositive donor - having passed medical for stem cell donation
9. Subject and Donor must have negative serology for Human immunodeficiency virus (HIV), Hepatitis B and C, syphilis
10. human leukocyte antigen (HLA) type A\*0101, A\*0201, A\*2402, B\*0702 and B\*0801
11. Donor informed consent for stem cell mobilisation leucapheresis and storage
Exclusion Criteria:
1. Pregnant or lactating women
2. Co-existing medical problems that would place the patient at significant risk of death due to Graft versus Host Disease (GVHD) or its sequelae
3. Human immunodeficiency virus infection
4. Active acute Graft versus Host Disease (GVHD) \> Grade I (to be assessed prior to CMV-specific T cell infusion )
5. Concurrent use of systemic corticosteroids(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion )
6. Organ dysfunction (to be assessed prior to cytomegalovirus-specific T cell infusion ) as measured by:
1. creatinine \> 200 uM/l
2. bilirubin \> 50 uM/l
3. alanine transferase \> 3x upper limit of normal
7. Donor pregnant or lactating
8. Donor platelets \< 50x109/l
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01220895
Study Brief:
Protocol Section:
NCT01220895