Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)Phase 2NCT02150928
An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)
A Phase 2 study testing Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) in people with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL), run by Jazz Pharmaceuticals at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
- What is being tested?
- Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a diagnosis of ALL or LBL
- Be 18 to <40 years of age at the time of enrollment
- Have a documented ≥ Grade 2 clinical hypersensitivity reaction to native E. coli asparaginase (e.g., Elspar or Kidrolase) or pegaspargase (Oncaspar)
- Have the following asparaginase doses remaining in their treatment plan:
- At least two (2) consecutive weeks of native E. coli asparaginase treatment OR
- At least one (1) dose of pegaspargase (Oncaspar)
Show all 11Show fewer
- Have a direct bilirubin ≤ Grade 2 (<3.0 mg/dL [52 µmol/L])
- Have amylase and lipase within normal limits (per institutional standards)
- Have a serum asparaginase activity below the detectable limit during screening prior to the first dose of study drug (Erwinaze)
- Consent to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, birth control pills or patches, diaphragm and spermicide, condom and vaginal spermicide, surgical sterilization, postmenopausal, vasectomy (>6 months prior to baseline), and progestin implant or injection.
- Have signed informed consent
Who cannot join
- Prior history of ≥ Grade 3 pancreatitis
- Prior history of a major thrombotic event as assessed by the investigator, or any subject with a history of asparaginase-associated serious hemorrhagic or thrombotic event requiring prolonged anticoagulation therapy with agents such as heparin
- Prior treatment with Erwinaze
- Pregnant or lactating female subjects or female subjects of childbearing potential not willing to use an adequate method of birth control (listed above) for the duration of the study
- Subjects with a history of human immunodeficiency virus (HIV) or hepatitis.
- Any other condition that would cause a risk (in the investigator's judgment) to subjects if they participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) Administered Following Hypersensitivity to E. Coli Asparaginase in Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase.
- Being tested
- Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)Drug
- Enrolled patients will receive asparaginase Erwinia chrysanthemi 25,000 IU/m2 administered intramuscularly (IM) on a Monday/Wednesday/Friday schedule (all dosing regimens will start on a Monday)
- All patients will receive at least 1 course (2 weeks) of treatment with asparaginase Erwinia chrysanthemi (1 course=6 doses), and a maximum number of courses needed to complete their remaining asparaginase therapy (up to 15 courses)
- Eligible patients may not begin treatment with asparaginase Erwinia chrysanthemi until their serum asparaginase activity level is below the assay detectable limit
| Study group | Role | What they receive |
|---|---|---|
| Erwinaze / Erwinase | Experimental | Not described Receives: Drug: Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum asparaginase activity levels
Measured: 48 h postdose 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)Studies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bengt Bergstrom, Md, PhD, Study director, Jazz Pharamceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150928
- Sponsor's protocol ID
- 13-006
- Status last verified
- May 2015
- First submitted
- 21 May 2014
- Last updated
- 13 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) Administered Following Hypersensitivity to E. Coli Asparaginase in Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT02150928
- Acronym / sponsor ID
- 13-006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2015 (estimated)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erwinaze / Erwinase | Experimental | Drug: Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Have a diagnosis of ALL or LBL
- Be 18 to <40 years of age at the time of enrollment
- Have a documented ≥ Grade 2 clinical hypersensitivity reaction to native E. coli asparaginase (e.g., Elspar or Kidrolase) or pegaspargase (Oncaspar)
- Have the following asparaginase doses remaining in their treatment plan:
- Have a direct bilirubin ≤ Grade 2 (<3.0 mg/dL [52 µmol/L])
Key exclusion criteria (6 listed)
- Prior history of ≥ Grade 3 pancreatitis
- Prior history of a major thrombotic event as assessed by the investigator, or any subject with a history of asparaginase-associated serious hemorrhagic or thrombotic event requiring prolonged anticoagulation therapy with agents such as heparin
- Prior treatment with Erwinaze
- Pregnant or lactating female subjects or female subjects of childbearing potential not willing to use an adequate method of birth control (listed above) for the duration of the study
- Subjects with a history of human immunodeficiency virus (HIV) or hepatitis.
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 |
|---|---|---|
| Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)* Enrolled patients will receive asparaginase Erwinia chrysanthemi 25,000 IU/m2 administered intramuscularly (IM) on a Monday/Wednesday/Friday schedule (all dosing regimens will start on a Monday) * All patients will receive at least 1 course (2 weeks) of treatment with asparaginase Erwinia chrysanthemi (1 course=6 doses), and a maximum number of courses needed to complete their remaining asparaginase therapy (up to 15 courses) * Eligible patients may not begin treatment with asparaginase Erwinia chrysanthemi until their serum asparaginase activity level is below the assay detectable limit | Drug | Erwinaze / Erwinase |
Primary outcome
Serum asparaginase activity levels
Time frame: 48 h postdose 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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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.
Bengt Bergstrom, Md, PhD study director
Jazz Pharamceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) in people with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL), run by Jazz Pharmaceuticals at 1 site in Spain.
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 11 inclusion and 6 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: withdrawn, as of the sponsor's last update on 13 May 2015. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Serum asparaginase activity levels (time frame: 48 h postdose 5). 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 13 May 2015.