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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT04094766
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent could be acquired;
2. Diagnosed with relapse/refractory acute lymphoblastic leukemia;
3. Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;
4. Refractory was defined as failed to achieve complete remission after two courses of induction therapy;
5. CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;
6. Karnofsky score ≥70;
7. Results of pregnant test should be negative, and agree to conception control during treatment and 6 months after CAR-T infusion.
8. Adequate organ function: EF≥50%; normal ECG; CCR ≥ 50ml/min or Cr \< 2.0mg/dL or \< 2 times upper limitation of normal; ALT and AST\<5 times upper limitation of normal; Serum bilirubin ≤ 3.0mg/dL; DLCO or FEV1 \> 45% of predict value;
9. At least 2 weeks intervals since the last chemotherapy;
10. At least 2 weeks intervals since the last anti-GVHD therapy if patients have ever ;
Exclusion Criteria:
1. Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);
2. Women in pregnancy and lactation;
3. Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;
4. Long term use of systemic corticosteroids(5mg per day for 2 weeks);
5. Any other uncontrolled life-threaten diseases;
6. Patients with history of anaphylaxis to any drugs;
7. With central nervous system (CNS) involvement;
8. Patients with GVHD after allo-HSCT who needed immunosuppressive agents ;
9. Patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis;
10. Other conditions that principle investigator considered may increase the risk of the patients or interference the results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
60 Years
Study:
NCT04094766
Study Brief:
Protocol Section:
NCT04094766