Erwinase Master Treatment Protocol (EMTP)

Phoenix Children's Hospital

Status

Conditions: Leukemia, Acute Lymphoblastic; Acute Lymphoid Leukemia

Treatments: Drug: Erwinia L-asparaginase

Study type: Expanded Access

Funder types: Other; Industry

Identifiers

NCT00590915

Erwinase

IND-290

Details and patient eligibility

About

The purpose of this study is to make Erwinase available to patients with acute lymphoblastic leukemia (ALL) who have had previous allergic reactions to certain formulations of L-asparaginase.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must give written informed consent to receive Erwinase.
• Patient must be treated for acute lymphoblastic leukemia.
• Patient must have either systemic hypersensitivity reactions to native (Elspar) or pegylated E.coli asparaginase (Oncaspar). This includes patients with generalized rash with or without anaphylactic symptoms, or patients with previously documented local or systemic reactions to E.coli derived L-asparaginase.

Exclusion criteria

• Previous allergic reaction to Erwinia L-asparaginase (Erwinase)
• Previous acute pancreatitis
• Pregnant or lactating woman