Erwinase Study in Patients With Acute Lymphoblastic Leukemia

NCT ID: NCT00506597

Last Updated: 2014-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-02-29

Brief Summary

The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase (Erwinase®) as a replacement for patients who are allergic to E.coli L-asparaginase or Pegylated E.coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia (ALL) or T or B cell lymphoma.

This trial was part of a multi institutional effort by the drug company to make Erwinase available for use.

Detailed Description

The Study Drug:

Erwinia L-Asparaginase helps stop the growth of cancer cells by blocking the nutrients that cancer cells needed to survive.

Study Visits:

Erwinia L-Asparaginase will be given either outpatient or inpatient, depending upon your condition.

If you are allergic to E. Coli Asparaginase or Pegylated Asparaginase, you will be given 6 doses every other day.

You will receive Erwinia L-Asparaginase as an injection through a needle in your vein, under the skin, or in your muscle, as directed by your study doctor.

You will be monitored closely by your nurse and your doctor before, during, and after receiving the drug for any side effects. If you develop a severe allergy to Erwinia L-Asparaginase, you may not receive any more asparaginase therapy.

The length of study will be based upon on the ALL treatment you are currently receiving. Your doctor will discuss the details of your treatment schedule with you.

This is an investigational study. Erwinia L-Asparaginase is not FDA approved. The FDA allows patients with acute lymphoblastic leukemia who have an allergic reaction to the U.S.-approved L-asparaginases to receive Erwinia L-Asparaginase. Up to 35 patients will take part in this study at The University of Texas (UT) MD Anderson Cancer Center.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erwinase

6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase

Group Type: EXPERIMENTAL

Erwinase

Intervention Type: DRUG

If allergic to E.Coli Asparaginase = 1 Dose (20,000 Units/m\^2) Daily; If allergic to Pegylated Asparaginase = 6 Doses (25,000 Units/m\^2) Daily Every Other Day. Received as an injection through a needle in vein, under the skin, or in muscle.

Interventions

Erwinase

If allergic to E.Coli Asparaginase = 1 Dose (20,000 Units/m\^2) Daily; If allergic to Pegylated Asparaginase = 6 Doses (25,000 Units/m\^2) Daily Every Other Day. Received as an injection through a needle in vein, under the skin, or in muscle.

Intervention Type: DRUG

Other Intervention Names

Erwinia L-Asparaginase

Eligibility Criteria

Inclusion Criteria

1. Age: no restrictions

2. Patient must give written informed consent to receive Erwinase® under Investigational New Drug (IND) 290.

3. Patient must be treated for Acute Lymphoblastic Leukemia

4. Patient with either T or B cell lymphoma being treated with Asparaginase.

5. Patient must have either systemic hypersensitivity reactions to native (Elspar®) or pegylated (Oncaspar®) E. coli L-Asparaginase. This includes patients with generalized rash with or without anaphylactic symptoms, but not those with only local pain or redness at the site of injection.

6. Patient with previously documented local or systemic reactions to E. coli derived L-Asparaginase.

7. Patients who are on Elspar® (including those enrolled in a clinical trial randomized to Elspar®) and where Elspar® is not available.

Exclusion Criteria

1. Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)

2. Previous acute pancreatitis

3. Pregnant or lactating woman

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J. Wells, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

UT MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

The University of Texas MD Anderson Cancer Center Official Website

Other Identifiers

2007-0183

Identifier Type: -

Identifier Source: org_study_id