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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT00957320
Eligibility Criteria:
Inclusion Criteria:
1. Less than 21 years old.
2. Acute lymphoblastic leukemia.
3. Second or greater bone marrow relapse or 1st relapse and refractory to at least 2 Attempts at re-induction.
4. Life expectancy of at least 8 weeks.
5. Fully recovered from the acute toxic effects of all prior therapy.
6. Appropriate organ function.
Exclusion Criteria:
1. Patients with a documented history of ≥ grade 3 local or systemic reactions to PEG-asparaginase.
2. Patients with a documented history of anti-E. coli asparaginase antibodies.
3. Patients with a history of ≥ grade 3 pancreatitis.
4. Patients with an active and uncontrolled infection.
5. Patients s/p allogeneic bone marrow transplantation, who are still on immunosuppressants.
6. Pregnant or lactating females. Women of childbearing age will agree to use contraception during the protocol.
7. Patients currently receiving other investigational agents, medications, or supplements with a known anti-leukemic effect.
8. Other concomitant medications that may alter the metabolism of Sirolimus (See section 7.2).
9. Patients who, in the opinion of the investigator, will not be able to comply with safety monitoring requirements of the study.
10. Patients with a history of a documented thrombus from previous asparaginase therapy.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00957320
Study Brief:
Protocol Section:
NCT00957320