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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT04067518
Eligibility Criteria:
Inclusion Criteria:
* Age 1 to ≤21 years at the time of informed consent;
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2;
* Newly diagnosed, untreated precursor B-cell ALL
* No prior therapy for malignant tumor such as chemotherapy and radiation therapy before signing the informed consent;
* Life expectancy of at least 6 months from the date of enrollment;
Exclusion Criteria:
* Mature B-cell ALL ; Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL
* Preexisting known coagulopathy ;
* History of pancreatitis;
* Continuous use of corticosteroids;
* Prior treatment or possible prior treatment with an L-asparaginase preparation;
* History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs;
* Pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT04067518
Study Brief:
Protocol Section:
NCT04067518