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AALL1931 An Open-Label, Multicenter Study of RC-P in Patients with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E.coli-derived Asparaginases

NCT04145531

An Open-Label, Multicenter Study of RC-P in Patients with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E.coli-derived Asparaginases

Associated Conditions

Leukemia

Principal Investigator

Sponsor

Children's Oncology Group

When patients become allergic to PEG-asparaginase, they may receive another form of asparaginase called RC-P. This asparaginase preparation is not yet approved by the FDA and is considered experimental. RC-P is investigational for patients who have ALL and LBL and are allergic to other forms of asparaginase. This preparation has been given to healthy adult volunteers and the side effects known to date are similar to those that occur with the other forms of asparaginase. We want to collect blood samples from you so that we can do the research tests to verify that the replacement doses of RC-P act in a similar way to doses or PEG-asparaginase in the body.