Acute Lymphoblastic LeukemiaPhase 3NCT00784017
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
A Phase 3 study testing asparaginase and recombinant asparaginase in people with Acute Lymphoblastic Leukemia, run by medac GmbH at 1 site in Netherlands.
Trial summary
This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- asparaginase and recombinant asparaginase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2008to Oct 2012
- Phase
- Phase 3
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Previously untreated T-lineage or precursor B-lineage ALL
- Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with more than 25% blasts
- Written informed consent
- Treatment according to DCOG ALL 10 protocol
Who cannot join
- Mature B-lineage ALL
- Patients with secondary ALL
- Known allergy to any ASNase preparation
- General health status according to Karnofsky / Lansky score < 40%
- Pre-existing known coagulopathy (e.g. haemophilia)
- Pre-existing pancreatitis
Show all 9Show fewer
- Liver insufficiency (Bilirubin > 50 µmol/L; SGOT/SGPT > 10 x ULN)
- Other current malignancies
- Pregnancy (planned or existent), breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- asparaginase, recombinant asparaginase
- Keywords
- Children with previously untreated acute lymphoblastic leukemia
- 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.
asparaginaseDrug
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
recombinant asparaginaseDrug
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
| Study group | Role | What they receive |
|---|---|---|
| asparaginase medac | Active comparator | Not described Receives: Drug: asparaginase |
| 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.
To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter
Measured: March 2012
Secondary outcomes (1)
To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment
Measured: March 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- medac GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784017
- Sponsor's protocol ID
- MC-ASP.5/ALL
- Other IDs
- EudraCT number 2006-003180-31
- Status last verified
- Feb 2013
- First submitted
- 31 Oct 2008
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Sluis IM, de Groot-Kruseman H, Te Loo M, Tissing WJE, van den Bos C, Kaspers GJL, Bierings M, Kollen WJW, Konig T, Pichlmeier U, Kuhnel HJ, Pieters R. Efficacy and safety of recombinant E. coli asparaginase in children with previously untreated acute lymphoblastic leukemia: A randomized multicenter study of the Dutch Childhood Oncology Group. Pediatr Blood Cancer. 2018 Aug;65(8):e27083. doi: 10.1002/pbc.27083. Epub 2018 May 4.
PubMed 29727043
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
- ClinicalTrials.gov ID
- NCT00784017
- Acronym / sponsor ID
- MC-ASP.5/ALL
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Children with previously untreated acute lymphoblastic leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- medac GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Nov 2008 (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 multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asparaginase medac | Active comparator | Drug: asparaginase |
| recombinant asparaginase | Experimental | Drug: recombinant asparaginase |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Previously untreated T-lineage or precursor B-lineage ALL
- Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with more than 25% blasts
- Written informed consent
- Treatment according to DCOG ALL 10 protocol
Key exclusion criteria (9 listed)
- Mature B-lineage ALL
- Patients with secondary ALL
- Known allergy to any ASNase preparation
- General health status according to Karnofsky / Lansky score < 40%
- 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 |
|---|---|---|
| asparaginase5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33 | Drug | asparaginase medac |
| recombinant asparaginase5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33 | Drug | recombinant asparaginase |
Primary outcome
To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter
Time frame: March 2012
1 secondary outcome
To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment
Time frame: March 2012
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 27 Feb 2013.
- Derived from this study: PubMed 29727043van der Sluis IM, de Groot-Kruseman H, Te Loo M, Tissing WJE, van den Bos C, Kaspers GJL, Bierings M, Kollen WJW, Konig T, Pichlmeier U, Kuhnel HJ, Pieters R. Efficacy and safety of recombinant E. coli asparaginase in children with previously untreated acute lymphoblastic leukemia: A randomized multicenter study of the Dutch Childhood Oncology Group. Pediatr Blood Cancer. 2018 Aug;65(8):e27083. doi: 10.1002/pbc.27083. Epub 2018 May 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing asparaginase and recombinant asparaginase in people with Acute Lymphoblastic Leukemia, run by medac GmbH at 1 site in Netherlands.
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 4 inclusion and 9 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 27 Feb 2013. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter (time frame: March 2012). 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 NCT00784017, 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 27 Feb 2013.