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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT03146468
Eligibility Criteria:
Inclusion Criteria:
* Prior allogeneic stem cell transplant for a haematological malignancy
* Confirmed relapse of haematological malignancy or persistent disease post-alloSCT
* Immunosuppression cessation for minimum of 2 weeks
* Life expectancy \> 2 months
* ECOG performance status 0-2
* Greater than or equal to 30% CD3+ donor chimerism
* Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 40mL/min
* AST and ALT ≤ 3 times upper limit of normal
* Total bilirubin ≤ 1.5 times upper limit of normal (except patients with Gilbert Syndrome)
* Signed written informed consent
Exclusion Criteria:
* Current evidence of any grade of GVHD
* Prior history of grade 2 or higher acute GVHD
* Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD
* Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger)
* Positive hepatitis B virus surface antigen
* Positive hepatitis C virus antibody
* Known human immunodeficiency virus infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03146468
Study Brief:
Protocol Section:
NCT03146468