Leukemia
Conditions
Keywords
Acute Lymphoblastic Leukemia, Leukemia, Erwinia L-Asparaginase, Erwinase
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.
Interventions
DRUGErwinase
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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Toxicity Data | 3 Years | Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting. |
| 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 | 4 years | Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290. |
Countries
United States
Participant flow
Recruitment details
The University of Texas (UT) MD Anderson Cancer Center Recruitment Period: May 07, 2007 to November 29, 2011. Recruitment site specifically at MD Anderson Cancer Center medical clinics.
Pre-assignment details
This trial was part of a multi institutional effort by the drug company to make Erwinase available for use. The participants reported were recruited and treated as part of the trial site participation at MD Anderson Cancer Center.
Participants by arm
| Arm | Count |
|---|---|
| Erwinase 6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Erwinase |
|---|---|
| Age, Continuous | 15 years |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 33 |
| serious Total, serious adverse events | 7 / 33 |
Outcome results
Primary
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
Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290.
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erwinase | 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 | 33 participants |
Primary
Participant Toxicity Data
Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
Time frame: 3 Years