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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT04384393
Eligibility Criteria:
Inclusion Criteria:
1. Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.
2. No alternative treatment options deemed by investigator.
3. Measurable or detectble disease at time of enrollment.
4. Eastern cooperative oncology group (ECOG) performance status of ≤2.
5. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
6. Estimated life expectancy \> 12 weeks deemed by investigator.
7. Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl .
8. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 upper limit of normal (ULN).
9. Informed consent explained to, understood by and signed by patient/guardian.
Exclusion Criteria:
1. Pregnant or lactating women
2. Uncontrolled infection
3. Active hepatitis B virus or hepatitis C virus infection.
4. Patients who need steroids to control disease.
5. Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days.
6. Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator.
7. History of Human Immunodeficiency Virus (HIV) infection.
8. Patients with active central nervous system (CNS) involvement by malignancy.
9. Patients combine with other disease cause neutrophil count (ANC) \< 750 per microlitre or platelet count (PLT)\< 50,000 per microlitre.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
70 Years
Study:
NCT04384393
Study Brief:
Protocol Section:
NCT04384393