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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT00671034
Eligibility Criteria:
Inclusion Criteria:
* Patients must be eligible for and enrolled on AALL08B1 or the successor classification study
* Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health Organization \[WHO\] 2008 classification) (also termed B-precursor acute lymphoblastic leukemia)
* White blood cell (WBC) \>= 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids
* Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal therapy
* Patients receiving prior steroid therapy are eligible for this study; the dose and duration of previous steroid therapy should be carefully documented
* Pregnancy tests with a negative result must be obtained in all post-menarchal females
* Lactating females must agree that they will not breastfeed a child while on this study
Exclusion Criteria:
* Patients with Down syndrome are excluded from this study
* Patients with testicular leukemia at diagnosis are excluded from this study
* Pregnant female patients are excluded from this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
30 Years
Study:
NCT00671034
Study Brief:
Protocol Section:
NCT00671034