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 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT04817761
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥22 and \<55 years with newly-diagnosed and cytologically confirmed and documented Philadelphia-negative B-cell or T-cell ALL by World Health Organization (WHO) classification (2016).
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2.
* No prior therapy for ALL such as chemotherapy and radiation therapy before signing the informed consent except for limited treatment (≤7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.
Exclusion Criteria:
* Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016).
* Patients with Down syndrome.
* Patients with Hepatitis B (positive for HBs antigen), and Hepatitis C (HCV antibody) at inclusion
* Participants known to be HIV-positive.
* Known history of non-gallstone-related pancreatitis.
* Known severe hepatic impairment (bilirubin \>3 x upper limit of normal \[ULN\]; transaminases \>10 times ULN.
* Pre-existing history of hepatic veno-occlusive disease (VOD).
* Age ≥ 55 years.
* BMI \> 35 kg/m2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
55 Years
Study:
NCT04817761
Study Brief:
Protocol Section:
NCT04817761