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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT00049569
Eligibility Criteria:
Inclusion Criteria:
* Patients with acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow), with or without associated extramedullary disease; this includes patients who are Philadelphia chromosome-positive
* Shortening fraction of \>= 28% by echocardiogram, or ejection fraction of \>= 50% by gated radionuclide study
* Cumulative prior anthracycline exposure of =\< 350 mg/m\^2 (each 10 mg/m\^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m\^2 of daunorubicin or adriamycin)
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with B-cell ALL (L3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
* Patients with Down syndrome are excluded due to the administration of methotrexate in Block 2
* Patients who have undergone prior stem cell transplantation (SCT) are ineligible if:
* They received SCT less than 12 months prior to study entry
* They are still receiving immunosuppression for the treatment of graft-versus-host disease (GVHD)
* They have active fungal infection at time of study entry
* They have had invasive filamentous fungal infection at any time post-SCT
* Pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
* Patients with prior isolated extramedullary relapse are ineligible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT00049569
Study Brief:
Protocol Section:
NCT00049569