An interventional study of Erwinase in Leukemia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-09-11.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment
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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 33 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 579 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
Drug: 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.
Also known as: Erwinia L-Asparaginase
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
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
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.
| Milestone | Erwinase |
|---|---|
| Started | 33 |
| Completed | 33 |
| Not completed | 0 |
Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
Results for this outcome have not been posted.
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.
| participants | 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 |
Collected over Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erwinase | — | 7/33 (21.2%) | 6/33 (18.2%) |
| Event | Erwinase |
|---|---|
| InfectionInfections and infestations | 4/33 |
| HyperglycemiaBlood and lymphatic system disorders | 1/33 |
| White Blood Count DecreasedBlood and lymphatic system disorders | 1/33 |
| Cardiopulmonary FailureCardiac disorders | 1/33 |
| Event | Erwinase |
|---|---|
| Allergic ReactionImmune system disorders | 1/33 |
| Fever/InfectionInfections and infestations | 1/33 |
| Muscle WeaknessMusculoskeletal and connective tissue disorders | 1/33 |
| ParathesiaMusculoskeletal and connective tissue disorders | 1/33 |
| Facial WeaknessMusculoskeletal and connective tissue disorders | 1/33 |
| HeadacheGeneral disorders | 1/33 |
| Prothrombin time (PTT) increasedBlood and lymphatic system disorders | 1/33 |
| PancreatitisEndocrine disorders | 1/33 |
| PancytopeniaBlood and lymphatic system disorders | 1/33 |
| HypokalemiaMetabolism and nutrition disorders | 1/33 |
| Age, Continuous(years) | Erwinase |
|---|---|
| Median | 15 (2 to 54) |
| Sex: Female, Male(Participants) | Erwinase |
|---|---|
| Female | 14 |
| Male | 19 |
| Region of Enrollment(participants) | Erwinase |
|---|---|
| United States | 33 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center