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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT03984968
Eligibility Criteria:
Inclusion Criteria:
* 15-65 years of age at the time of signing informed consent
* Diagnosed as de novo Philadelphia chromosome-positive CD19+ B-ALL
* Karnofsky performance status ≥ 60 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Unable to find a suitable donor or for other reasons to undergo allogeneic hematopoietic stem cell transplantation during the study
* Ability and willingness to adhere to the study visit schedule and all protocol requirements
* Voluntarily sign informed consent forms
Exclusion Criteria:
* Unable to tolerate any kind of TKIs (including the first- and second-generation tyrosine kinase inhibitors) for a long period.
* Subjects who have positive mutation(s) of the ABL kinase domain and require the third-generation tyrosine kinase inhibitors for long-term therapies.
* Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 × upper limit of normal (ULN) and direct bilirubin \> 1.5 × ULN
* Inadequate renal function defined by serum creatinine \> 1.6 mg/dL
* International ratio (INR) or partial thromboplastin time (PTT) \> 1.5 x ULN
* Left ventricular ejection fraction \< 50%
* Ongoing treatment with chronic immunosuppressants
* Significant comorbid conditions or diseases which, in the judgment of the investigator, would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions
* Known human immunodeficiency virus (HIV) positivity
* Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
* Subjects with second malignancies in addition to ALL
* Pregnant or lactating women, or subjects refusing to take effective contraception measures
* Other contraindications that are considered inappropriate to participate in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
65 Years
Study:
NCT03984968
Study Brief:
Protocol Section:
NCT03984968