Clinical Trial Detail

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

Complete title: 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

Research Study Number RG1006728
Principal Investigator Doug Hawkins, MD
Phase II/III

Look up trial at NIH

Research Study Description

This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in patients who develop hypersensitivity to an E. coli-derived asparaginase), as measured by asparaginase activity.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above **

Other eligibility criteria may apply.

Research Study Number RG1006728

Keywords: Leukemia, Acute Lymphoblastic (ALL); Lymphoma, Lymphoblastic (LBL)

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Last Modified, June 25, 2019