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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07493161
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).
* Age ≥ 14 years.
* ECOG performance status ≤ 2.
* Adequate organ function: Total bilirubin \<1.5x ULN; AST/ALT ≤2.5x ULN; Serum creatinine \<2x ULN; Cardiac enzymes \<2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) \>45%.
* Male and female patients of childbearing potential must agree to use effective contraception.
* Signed informed consent.
Exclusion Criteria:
* Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.
* Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).
* Myocardial infarction within 12 months prior to enrollment; uncontrolled/unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.
* Uncontrolled active severe infection.
* Active psychiatric illness that may hinder treatment completion or informed consent.
* Any other condition deemed unsuitable for the study by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT07493161
Study Brief:
Protocol Section:
NCT07493161