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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT02046694
Eligibility Criteria:
Inclusion Criteria:
* Currently being treated in the maintenance phase of therapy for pediatric ALL
* Age ≤30 years
* 6-MMP:6-TGN ratio ≥40 within 21 days prior to enrollment
* 6-MMP ≥12,000/8x108 red blood cells (RBC) within 21 days prior to enrollment
* One of the following within 21 days prior to enrollment:
1. ANC persistently ≥1500/mm3 (as measured by 3 CBCs done over 6 weeks or 2 successive monthly complete blood counts (CBCs) despite 6-MP ≥150% of Children's oncology group (COG) dosing OR
2. Evidence of ≥ Grade 3 hepatotoxicity with one of the following:
ALT ≥5x upper limit of normal (based on institutional standards) AST ≥5x upper limit of normal (based on institutional standards) Direct bilirubin ≥5x upper limit of normal (based on institutional standards) OR
3. Evidence of ≥ Grade 2 gastrointestinal toxicity (including, but not limited to: nausea, vomiting, anorexia, gastrointestinal pain)
Exclusion Criteria:
* Allergy to allopurinol
* Active relapse of ALL or lymphoblastic lymphoma
* Currently enrolled on any therapeutic research study for the treatment of ALL or lymphoblastic lymphoma
* Known history of chronic liver disease (other than Gilbert's syndrome)
* Pregnant or breastfeeding females
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT02046694
Study Brief:
Protocol Section:
NCT02046694