Erwinase Study in Patients With Acute Lymphoblastic Leukemia

Condition(s) targeted: Leukemia

Intervention: Erwinase (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Robert J. Wells, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Robert J. Wells, MD, Phone: 713-563-1499

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).

Official title: Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patient Toxicity Data

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 their condition.

If you are allergic to E. Coli Asparaginase, then you will receive one dose of Erwinia L-Asparaginase, once a day.

If you are allergic to Pegylated Asparaginase, you will be given 6 doses of Erwinia L-Asparaginase 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.

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 25 patients will take part in this study. All will be enrolled at M. D. Anderson.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Age: no restrictions

2. Patient must give written informed consent under 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.

Exclusion Criteria:

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

2. Previous acute pancreatitis

3. Pregnant or lactating woman

Robert J. Wells, MD, Phone: 713-563-1499

U.T.M.D. Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Robert J. Wells, MD, Principal Investigator

MD Anderson Cancer Center website

Starting date: May 2007
Last updated: May 10, 2010