Status:
WITHDRAWN
Study of Sirolimus With PEG-Asparaginase in Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Emory University
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
The goal of this study is to find a safe dose of sirolimus that can be used with a standard dose of L-asparaginase. To find the safe dose, the investigators will give the first patient a very small do...
Detailed Description
Multiple relapsed acute lymphoblastic leukemia (ALL) has a very poor cure rate, and there is no standard of care for treatment of these patients. Therefore, we want to combine two chemotherapy drugs t...
Eligibility Criteria
Inclusion
- Less than 21 years old.
- Acute lymphoblastic leukemia.
- Second or greater bone marrow relapse or 1st relapse and refractory to at least 2 Attempts at re-induction.
- Life expectancy of at least 8 weeks.
- Fully recovered from the acute toxic effects of all prior therapy.
- Appropriate organ function.
Exclusion
- Patients with a documented history of ≥ grade 3 local or systemic reactions to PEG-asparaginase.
- Patients with a documented history of anti-E. coli asparaginase antibodies.
- Patients with a history of ≥ grade 3 pancreatitis.
- Patients with an active and uncontrolled infection.
- Patients s/p allogeneic bone marrow transplantation, who are still on immunosuppressants.
- Pregnant or lactating females. Women of childbearing age will agree to use contraception during the protocol.
- Patients currently receiving other investigational agents, medications, or supplements with a known anti-leukemic effect.
- Other concomitant medications that may alter the metabolism of Sirolimus (See section 7.2).
- Patients who, in the opinion of the investigator, will not be able to comply with safety monitoring requirements of the study.
- Patients with a history of a documented thrombus from previous asparaginase therapy.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00957320
Start Date
June 1 2009
End Date
August 1 2012
Last Update
December 3 2013
Active Locations (1)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322