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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00016302
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed T-cell acute lymphoblastic leukemia with greater than 25%bone marrow blasts (M3)
* High-risk disease, defined as meeting at least 1 of the following criteria:
* WBC at least 50,000/mm\^3
* Age 10 years or over
* Patients with WBC at least 25,000/mm\^3 AND at least 50% peripheral blood blasts are eligible provided bone marrow aspiration was contraindicated (e.g., patient was not eligible for anesthesia or sedation due to respiratory distress secondary to anterior mediastinal mass)
* Concurrent registration to POG 9900 within the past 8 days required
* Performance status - Karnofsky 50-100% (over 10 years of age)
* Performance status - Lansky 50-100% (10 years of age and under)
* See Disease Characteristics
* Bilirubin no greater than 1.5 mg/dL
* SGPT less than 5 times normal
* Creatinine normal
* Creatinine clearance or glomerular filtration rate at least 60 mL/min
* No pre-existing neuropathy of grade 2 or worse unless due to leukemic infiltration
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior biologic therapy
* No more than 72 hours since prior intrathecal cytarabine
* No other prior chemotherapy
* Prior steroids allowed
* No chronic steroid treatment for another disease
* Prior emergency radiotherapy to mediastinum for severe respiratory distress allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT00016302
Study Brief:
Protocol Section:
NCT00016302