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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02186860
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-65 years
* Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
* Refractory or relapsed B cell-acute lymphoblastic leukemia
* No available curative treatment options (such as hematopoietic stem cell transplantation)
* Stage III-IV disease
* Creatinine \< 2.5 mg/dl
* Aspartate transaminase-alanine transaminase ratio \< 3x normal
* Bilirubin \< 2.0 mg/dl
* Karnofsky performance status \>= 60
* Expected survival time \> 3 months
* Adequate venous access for apheresis
* Ability to understand and provide informed consent
Exclusion Criteria:
* Pregnant or lactating women
* Patients requiring T cell immunosuppressive therapy
* Active central nervous system leukemia
* Any concurrent active malignancies
* Patients with a history of a seizure disorder or cardiac disorder
* Patients with human immunodeficiency virus, hepatitis B or C infection
* Uncontrolled active infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02186860
Study Brief:
Protocol Section:
NCT02186860