Acute Lymphoblastic LeukemiaPhase 2NCT01643408
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
A Phase 2 study testing asparaginase Erwinia chrysanthemi in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Jazz Pharmaceuticals at 22 sites in 2 countries.
Trial summary
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are >0.1 IU/mL during the first 2 weeks of… Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
- What is being tested?
- asparaginase Erwinia chrysanthemi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Nov 2012to Dec 2013
- Phase
- Phase 2
- 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 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
- Ages >/= 1 and </= to 30 years at the time of initial diagnosis
- Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
- Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
- Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
- Direct bilirubin less than or equal to Grade 2
- Amylase and lipase within normal limits (per institutional standards)
- Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.
Who cannot join
- -
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States18 sites
Children's Hospital
Aurora, Colorado, 80045
John Hopkins
Baltimore, Maryland, 21231
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Children's Memorial Hospital
Chicago, Illinois, 60611
Inova Fairfax Medical Center
Falls Church, Virginia, 22042
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Michigan, 55455
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, 55406
UMDNJ/Robert Wood Johnson
New Brunswick, New Jersey, 08903
Columbia Presbyterian Medical Center
New York, New York, 10032
Children's Hospital of Orange County
Orange County, California, 92868
Stanford Medical Center
Palo Alto, California, 94304
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Oregon Health & Sciences
Portland, Oregon, 97239
All Children's Hospital
St. Petersburg, Florida, 33701
Montifiore Medical Center
The Bronx, New York, 10467
Canada4 sites
McMasters University Medical Center
Hamilton, Ontario, L8S4R1
Hospital St. Justine
Saint Catherine, Quebec, H3T1CS
Quebec Children's Hospital
Sainte-Foy, Quebec, CIV462
Sick Children's Hospital
Toronto, Ontario, m561X8
About this study
Official title: Phase II, An Open Label, Single Arm, Multi-Center Pharmacokinetic Study of Intravenous Erwinaze (Asparaginase Erwinia Chrysanthemi)Following Allergy to Native E. Coli Asparaginase (Elspar or Kidrolase), Pegaspargase (Oncaspar) or Calaspargase Pegol (EZN-2285) in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma.
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
- Being tested
- asparaginase Erwinia chrysanthemi
- Keywords
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Erwinaze, asparaginase, Eusa Pharma, Pharmacokinetic study, NSAA
- 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.
asparaginase Erwinia chrysanthemiDrug
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Erwinaze | Experimental | Not described Receives: Drug: asparaginase Erwinia chrysanthemi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two Day Nadir Serum Asparaginase Activity (NSAA) Level
To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
Measured: 48 hours post-dose 5
Secondary outcomes (4)
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours
To report the proportion of participants achieving 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
Measured: 48 hours post-dose 5
Three Day NSAA Level
To report the mean 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
Measured: 72 hours post-dose 6
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours
To report the proportion of participants achieving 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
Measured: 72 hours post-dose 6
Nadir Serum Asparaginase Activity Over Time
To describe the NSAA over time in participants with ALL/Lymphoblastic Lymphoma who have/had developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol and are receiving intravenous Erwinaze 3 times per week for a prolonged duration (4-30 weeks).
Measured: 4 weeks to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionDec 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynda Vrooman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643408
- Sponsor's protocol ID
- 100EUSA12
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2012
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vrooman LM, Kirov II, Dreyer ZE, Kelly M, Hijiya N, Brown P, Drachtman RA, Messinger YH, Ritchey AK, Hale GA, Maloney K, Lu Y, Plourde PV, Silverman LB. Activity and Toxicity of Intravenous Erwinia Asparaginase Following Allergy to E. coli-Derived Asparaginase in Children and Adolescents With Acute Lymphoblastic Leukemia. Pediatr Blood Cancer. 2016 Feb;63(2):228-33. doi: 10.1002/pbc.25757. Epub 2015 Sep 16.
PubMed 26376459
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, An Open Label, Single Arm, Multi-Center Pharmacokinetic Study of Intravenous Erwinaze (Asparaginase Erwinia Chrysanthemi)Following Allergy to Native E. Coli Asparaginase (Elspar or Kidrolase), Pegaspargase (Oncaspar) or Calaspargase Pegol (EZN-2285) in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma.
- ClinicalTrials.gov ID
- NCT01643408
- Acronym / sponsor ID
- 100EUSA12
- Keywords
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Erwinaze, asparaginase, Eusa Pharma, Pharmacokinetic study, NSAA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Posted 23 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Erwinaze | Experimental | Drug: asparaginase Erwinia chrysanthemi |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
- Ages >/= 1 and </= to 30 years at the time of initial diagnosis
- Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
- Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
- Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| asparaginase Erwinia chrysanthemi | Drug | Open-Label Erwinaze |
Primary outcome
Two Day Nadir Serum Asparaginase Activity (NSAA) Level
Time frame: 48 hours post-dose 5
To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
4 secondary outcomes
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours
Time frame: 48 hours post-dose 5
Three Day NSAA Level
Time frame: 72 hours post-dose 6
Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours
Time frame: 72 hours post-dose 6
Nadir Serum Asparaginase Activity Over Time
Time frame: 4 weeks to 30 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26376459Vrooman LM, Kirov II, Dreyer ZE, Kelly M, Hijiya N, Brown P, Drachtman RA, Messinger YH, Ritchey AK, Hale GA, Maloney K, Lu Y, Plourde PV, Silverman LB. Activity and Toxicity of Intravenous Erwinia Asparaginase Following Allergy to E. coli-Derived Asparaginase in Children and Adolescents With Acute Lymphoblastic Leukemia. Pediatr Blood Cancer. 2016 Feb;63(2):228-33. doi: 10.1002/pbc.25757. Epub 2015 Sep 16.
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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.
Lynda Vrooman, MD principal investigator
Dana-Farber Cancer Institute
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing asparaginase Erwinia chrysanthemi in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Jazz Pharmaceuticals at 22 sites in 2 countries.
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 8 inclusion and 1 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2021). 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?
Two Day Nadir Serum Asparaginase Activity (NSAA) Level (time frame: 48 hours post-dose 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643408, which also lists 1 linked publication.
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 23 Jun 2021.