Clinical trial NCT00506597: Erwinase Study in Patients With Acute Lymphoblastic Leukemia
Official title: Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Keywords: Acute Lymphoblastic Leukemia
Leukemia
Erwinia L-Asparaginase
Erwinase
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participant Toxicity Data
timeFrame: 3 Years
measure: Number of Participants Treated With Erwinase as a Replacement for 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
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert J. Wells, MD
role: PRINCIPAL_INVESTIGATOR
References: