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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT03389035
Eligibility Criteria:
Inclusion Criteria:
* Children (1-17) and adults (18-75 years old);
* Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
* Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
* Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
* No evidence of overall aGVHD \> Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
* No longer taking immunosuppressive agents for at least 30 days prior to enrollment;
Exclusion Criteria:
* Patients with GVHD Grades II-IV;
* Any cell therapy in the last 30 days;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
75 Years
Study:
NCT03389035
Study Brief:
Protocol Section:
NCT03389035