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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT06389305
Eligibility Criteria:
Inclusion Criteria:
* A patient must meet all of the following to be enrolled:
1. A confirmed diagnosis of refractory or relapsed B-ALL (criteria reference: NCCN, 2024.4), where all patients meet the National Comprehensive Cancer Network(NCCN) guidelines for the diagnosis of acute lymphoblastic leukemia (hematopathological examination of bone marrow aspirate and biopsy tissue showing ≥20% lymphoblasts in the bone marrow, confirmed by comprehensive flow cytometry (FCM) immunotyping, minimal residual disease analysis, and G-banded metaphase chromosome karyotype analysis). Molecular characteristics can be described through methods such as interphase fluorescence in situ hybridization (FISH) testing, reverse transcription polymerase chain reaction (RT-PCR) testing, and next-generation sequencing (NGS) for comprehensive detection of fusion genes and pathogenic mutations. Determination can also be made by the World Health Organization's subtypes of acute lymphoblastic leukemia, as well as cytogenetic and clinical risk groups.
2. Loss of CAR-T cell activity within 6 months after previous CAR-T therapy and no relapse.
3. Age between 1 and 39 years old.
4. No severe allergic constitution.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
6. Life expectancy, as judged by the investigator, of at least 60 days.
7. Patients with self-awareness between 8 and 39 years of age voluntarily sign an informed consent, and the legal representative (guardians) of child patients under 18 years of age voluntarily signs an informed consent.
Exclusion Criteria:
* A patient with at least one of the following conditions will be excluded:
1. Received bendamustine treatment within the past 9 months;
2. Intracranial hypertension or impaired consciousness in the brain;
3. Symptomatic heart failure or severe arrhythmia;
4. Symptoms of severe respiratory failure;
5. With other types of malignant tumors;
6. Disseminated intravascular coagulation;
7. Serum creatinine and/or blood urea nitrogen ≥ 1.5 times the normal value;
8. Suffering from sepsis or other uncontrollable infections;
9. Uncontrollable diabetes;
10. Severe mental disorders;
11. Significant lesions in the brain as detected by head magnetic resonance imaging;
12. Leukemic cells in the cerebrospinal fluid \>20 cells/μL;
13. Peripheral blood leukemic cell proportion \>30%;
14. Have undergone organ transplantation;
15. Female patients (those with childbearing potential) are pregnant or lactating;
16. Active or uncontrollable infectious diseases, such as hepatitis (HBV, HCV), HIV, or syphilis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
39 Years
Study:
NCT06389305
Study Brief:
Protocol Section:
NCT06389305