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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT03131934
Eligibility Criteria:
Inclusion Criteria:
1. Adult and paediatric (age 1-70 years) solid organ transplant recipients with histologically proven B-lineage EBV+ post-transplant lymphoproliferative disease (PTLD) either de novo or resistant to Rituximab
2. EBV viraemia at enrolment
3. On immunosuppression with tacrolimus
4. Agreement to have a pregnancy test and use of contraception for duration of trial (if applicable)
5. Written informed consent
Exclusion Criteria:
1. Fulminant disease
2. Requirement for supplemental oxygen
3. Burkitt's lymphoma/Mature B-acute lymphoblastic leukaemia with IgH-Myc rearrangement
4. T-lineage PTLD
5. Bilirubin \> 3 x upper limit of normal
6. Creatinine \> 3 x upper limit of normal
7. Active hepatitis B, C or HIV infection
8. Women who are pregnant or breast-feeding
9. ECOG performance score ≥ 4
10. Inability to tolerate leucapheresis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
70 Years
Study:
NCT03131934
Study Brief:
Protocol Section:
NCT03131934