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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04340167
Eligibility Criteria:
Inclusion Criteria:
* Patients who were diagnosed as primary refractory or relapsed B-ALL. All the patients matched the diagnostic criteria of ALL according to the WHO classification and conducted morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis, screen of 56 leukemia-related fusion genes by multiplex nested reverse transcriptase-polymerase chain reaction (RT-PCR), and quantification of fusion genes by real-time PCR with ABL1 as reference.
* Extramedullary diseases (EMDs) were confirmed CD22+ by FCM and evaluated by positron emission tomography/computed tomography (PET/CT), CT, MRI or ultrasonography.
* The patient relapsed during chemotherapy or failed from re-induction chemotherapy (including first and second-generation TKIs) after relapse or had a persistent positive minimal residual disease (MRD) for three months. Patients had positive CD22 expression on leukemia blasts by FCM (\>95% CD22 positive);
* Age from 0 to 18 years old;
* Children candidates can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form.
Exclusion Criteria:
* Intracranial hypertension or unconscious;
* Acute heart failure or severe arrhythmia;
* Acute respiratory failure;
* Other types of malignant tumors;
* Diffuse intravascular coagulation;
* Serum creatinine and/or blood urea nitrogen over 1.5 times than normal range;
* Sepsis or other uncontrolled infection;
* Uncontrolled diabetes mellitus;
* Severe psychological disorder;
* Obvious cranial lesions with cranial MRI;
* More than 20 counts/ul leukemic cells in cerebrospinal fluid;
* More than 30% leukemic cells in the blood;
* Stage III WHO/ECOG score;
* Organ recipients;
* Pregnant or breastfeeding;
* Active, uncontrolled infection, including hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT04340167
Study Brief:
Protocol Section:
NCT04340167