LeukemiaNCT00506597
Erwinase Study in Patients With Acute Lymphoblastic Leukemia
A study testing Erwinase in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- Erwinase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: no restrictions
- Patient must give written informed consent to receive Erwinase® under Investigational New Drug (IND) 290.
- Patient must be treated for Acute Lymphoblastic Leukemia
- Patient with either T or B cell lymphoma being treated with Asparaginase.
- 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.
- Patient with previously documented local or systemic reactions to E. coli derived L-Asparaginase.
- Patients who are on Elspar® (including those enrolled in a clinical trial randomized to Elspar®) and where Elspar® is not available.
Who cannot join
- Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)
- Previous acute pancreatitis
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia
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.
Read the 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
- Being tested
- Erwinase
- Keywords
- Acute Lymphoblastic Leukemia, Leukemia, Erwinia L-Asparaginase, Erwinase
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErwinaseDrug
Also called Erwinia L-Asparaginase
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.
| Study group | Role | What they receive |
|---|---|---|
| Erwinase | Experimental | 6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase Receives: Drug: Erwinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Toxicity Data
Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J. Wells, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506597
- Sponsor's protocol ID
- 2007-0183
- Status last verified
- Sep 2014
- First submitted
- 20 Jul 2007
- Last updated
- 11 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00506597
- Acronym / sponsor ID
- 2007-0183
- Conditions
- Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, Leukemia, Erwinia L-Asparaginase, Erwinase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erwinase | Experimental | Drug: Erwinase6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age: no restrictions
- Patient must give written informed consent to receive Erwinase® under Investigational New Drug (IND) 290.
- Patient must be treated for Acute Lymphoblastic Leukemia
- Patient with either T or B cell lymphoma being treated with Asparaginase.
- 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.
Key exclusion criteria (3 listed)
- Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)
- Previous acute pancreatitis
- Pregnant or lactating woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErwinaseAlso: Erwinia L-AsparaginaseIf 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. | Drug | Erwinase |
Primary outcome
Participant Toxicity Data
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J. Wells, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erwinase in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Toxicity Data (time frame: 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.