Acute Lymphoid LeukemiaPhase 2NCT00983138
Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)
A Phase 2 study testing recombinant asparaginase in people with Acute Lymphoid Leukemia, run by medac GmbH at 17 sites in 2 countries.
Trial summary
This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia Read more about this study
- Who is it for?
- Ages Up to 364 days
- Conditions the study is for
- Acute Lymphoid Leukemia
- What is being tested?
- recombinant asparaginase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jul 2009to Feb 2011
- 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 Up to 364 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria.
- Morphological verification of the diagnosis, confirmed with cyto¬chemistry and immunophenotyping.
- Age < 1 year at diagnosis.
- Written informed consent of the parents or other legally authorised guardian of the patient.
- Treatment according to protocol INTERFANT 06
Who cannot join
- Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL.
- The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.
- Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.
- Known allergy to any ASNase preparation.
- Pre-existing known coagulopathy (e.g. haemophilia).
- Pre-existing pancreatitis.
- Liver insufficiency (bilirubin > 50 µmol/L; SGOT/SGPT > 10 x the upper limit of normal).
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Germany11 sites
Hospital Charité Virchow
Berlin, 13353
University Hospital Bonn
Bonn, 53113
University Hospital Erlangen
Erlangen, 91054
University Hospital Essen
Essen, 45147
University Hospital Johann Wolfgang Goethe
Frankfurt, 60590
University Hospital Freiburg
Freiburg im Breisgau, 79106
University Hospital Hamburg-Eppendorf
Hamburg, 20246
Medical University Hannover
Hanover, 30625
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, 24105
University Hospital Münster
Münster, 48149
Olga Hospital
Stuttgart, 70174
Netherlands6 sites
VU University Medical Centre
Amsterdam, 1081
Academic Medical Centre AMC/EK2
Amsterdam, 1105
University of Groningen
Groningen, 9713
University Children's Hospital Nijmegen
Nijmegen, 6500
Sophia Children's Hospital
Rotterdam, 3015
University Medical Centre Utrecht
Utrecht, 3584
About this study
Official title: Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial
This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia
- Conditions
- Acute Lymphoid Leukemia
- Being tested
- recombinant asparaginase
- 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.
recombinant asparaginaseDrug
10 000 Units/m² adjusted to age, 6 i.v. infusions (day 15, day 18, day 22, day 25, day 29, day 33) during the induction therapy
| Study group | Role | What they receive |
|---|---|---|
| recombinant asparaginase | Experimental | Not described Receives: Drug: recombinant asparaginase |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with hypersensitivity reactions to rASNase
Measured: within 2 months
Secondary outcomes (1)
pharmacodynamic of rASNase
Measured: within 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoid LeukemiaStudies of the same condition, open and under way.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- medac GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rob Pieters, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983138
- Sponsor's protocol ID
- MC-ASP.6/INF
- Other IDs
- EudraCT No: 2008-006300-27
- Status last verified
- Feb 2011
- First submitted
- 22 Sep 2009
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT00983138
- Acronym / sponsor ID
- MC-ASP.6/INF
- Conditions
- Acute Lymphoid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- medac GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Sep 2009 (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.
This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recombinant asparaginase | Experimental | Drug: recombinant asparaginase |
Who may qualify
- Ages
- Up to 364 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria.
- Morphological verification of the diagnosis, confirmed with cyto¬chemistry and immunophenotyping.
- Age < 1 year at diagnosis.
- Written informed consent of the parents or other legally authorised guardian of the patient.
- Treatment according to protocol INTERFANT 06
Key exclusion criteria (7 listed)
- Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL.
- The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.
- Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.
- Known allergy to any ASNase preparation.
- Pre-existing known coagulopathy (e.g. haemophilia).
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 |
|---|---|---|
| recombinant asparaginase10 000 Units/m² adjusted to age, 6 i.v. infusions (day 15, day 18, day 22, day 25, day 29, day 33) during the induction therapy | Drug | recombinant asparaginase |
Primary outcome
number of patients with hypersensitivity reactions to rASNase
Time frame: within 2 months
1 secondary outcome
pharmacodynamic of rASNase
Time frame: within 33 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
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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.
Rob Pieters, MD principal investigator
Erasmus Medical Center
17 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 recombinant asparaginase in people with Acute Lymphoid Leukemia, run by medac GmbH at 17 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 5 inclusion and 7 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 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of patients with hypersensitivity reactions to rASNase (time frame: within 2 months). 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 1 Mar 2011; AzTrials last refreshed its copy on 8 Nov 2026.