Erwinase Master Treatment Protocol - Full Text View

Erwinase Master Treatment Protocol (EMTP)

Expanded access is currently available for this treatment.

Verified by Phoenix Children's Hospital, April 2008

First Received: December 26, 2007 Last Updated: April 15, 2009 History of Changes

Sponsors and Collaborators:	Phoenix Children's Hospital Fisher Bioservices EUSA Pharma (US), Inc.
Information provided by:	Phoenix Children's Hospital
ClinicalTrials.gov Identifier:	NCT00590915

Purpose

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.

Condition	Intervention
Leukemia, Acute Lymphoblastic Acute Lymphoid Leukemia	Drug: Erwinia L-asparaginase

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: L-Asparaginase

U.S. FDA Resources

Study Type:	Expanded Access
Official Title:	Erwinase Master Treatment Protocol

Further study details as provided by Phoenix Children's Hospital:

Intervention Details:

Substitute Erwinia L-asparaginase 25,000 international units per meters squared, IM every other day (including weekends and holidays) x 6 doses for each dose of PEG-asparaginase that is replaced. NOTE: Erwinia L-asparaginase dosing to replace native E.coli L-asparaginase varies; consult protocol for specifics.

Eligibility

Genders Eligible for Study:

Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590915

Contacts

Contact: Paul Plourde, MD

215-230-9622

Paul.Plourde@eusapharma.com

Sponsors and Collaborators

Phoenix Children's Hospital

Fisher Bioservices

EUSA Pharma (US), Inc.

More Information

Additional Information:

Phoenix Children's Hospital This link exits the ClinicalTrials.gov site

EUSA Pharma (US), Inc.- manufacturer of Erwinase This link exits the ClinicalTrials.gov site

Fisher BioServices - U.S. distributor for Erwinase This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Phoenix Children's Hospital ( Jessica Boklan, MD/Director, Oncology Research )
Study ID Numbers:	Erwinase, IND-290
Study First Received:	December 26, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00590915 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Phoenix Children's Hospital:

ALL

Study placed in the following topic categories:

Asparaginase
Pegaspargase
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid

Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Asparaginase
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents

Pharmacologic Actions
Leukemia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 07, 2009