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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00905034
Eligibility Criteria:
Inclusion Criteria:
1. Previously treated ALL (including Burkitt's lymphoma) or lymphoblastic lymphoma in relapse or primary refractory; without viable stem cell transplant option. Patients with previously treated Philadelphia chromosome positive ALL will be also eligible;
2. Chronic myeloid leukemia in blast phase
3. Zubrod performance status \</= 3;
4. Adequate liver function (bilirubin \</= 3.0mg/dl, unless considered due to tumor),and renal function (creatinine \</= 3.0 mg/dl unless considered due to tumor;
5. Age \>/= to 1 year
6. Understand and voluntarily sign an informed consent form.
7. For pediatric patients (age \>/= 1 year to \</= 18 years), Lansky performance status \>/=50
8. For pediatric patients (age \>/= 1 year to \</= 18 years), second or greater relapse
Exclusion Criteria:
1. Pregnant patients
2. Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic event with PEG-l-asparaginase or its components.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT00905034
Study Brief:
Protocol Section:
NCT00905034