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 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT00846703
Eligibility Criteria:
Inclusion Criteria:
* Cytologically proven acute lymphoblastic leukemia (ALL)
* No relapse of a previously unrecognized ALL
* Patients must meet one of the following risk criteria:
* Standard-risk (SR) group meeting all of the following criteria:
* Blasts \< 1,000/μL in peripheral blood (PB) on day 8
* Aged 1 to \< 6 years
* Initial WBC \< 20,000/μL
* M1 (5%) or M2 (≥ 5% to \< 25%) blasts in bone marrow on day 15;
* M1 marrow on day 33.
* Intermediate-risk (IR) group meeting all of the following criteria:
* Aged \< 1 or ≥ 6 years and/or WBC ≥ 20,000/μL
* Blasts \< 1,000/μL in PB on day 8
* M1 or M2 marrow on day 15
* M3 (≥ 25%) marrow on day 15 OR meets SR criteria but M3 marrow on day 15 and \*M1 marrow on day 33.
* High-risk (HR) group meeting ≥ 1 of the following criteria:
* Meets IR criteria and M3 marrow on day 15 (not SR and M3 on day 15)
* Blasts ≥ 1,000/μL in PB on day 8
* M2 or M3 marrow on day 33
* Translocation t(9;22) \[BCR/ABL+\] (Philadelphia chromosome-positive) or t(4;11) \[MLL/AF4+\].
Exclusion Criteria:
* No Down syndrome
* No other major disease that prohibits study treatment (e.g., severe congenital heart disease)
* Not requiring significant therapy modification owing to study therapy associated complications
* No complications due to other interventions
* No one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
16 Years
Study:
NCT00846703
Study Brief:
Protocol Section:
NCT00846703