Acute Lymphoblastic LeukemiaPhase 3NCT00991744
Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL)
A Phase 3 study testing Liposomal cytarabine and Intrathecal triple in people with Acute Lymphoblastic Leukemia, run by Nordic Society for Pediatric Hematology and Oncology at 5 sites in 5 countries.
Trial summary
Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in high-risk ALL patients. Both acute and long-term toxicity are equal in both treatment arms. 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?
- Liposomal cytarabine and Intrathecal triple
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Jan 2009to Dec 2018
- 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
- High risk acute lymphoblastic leukemia
- Not eligible for bone marrow transplantation
- Age 1-18
- Written informed consent has been obtained
Who cannot join
- Persistent NCI grade 3-4 neurotoxicity from previous treatments
- Bilineage ALL
- Leukemia predisposing syndromes (e.g. Downs syndrome, Ataxia Telangiectasia)
- Previous cancer
- Known intolerance to NOPHO ALL 2008 anticancer agents
- Sexually active females will use safe contraceptives
- Previous treatment with intrathecal liposomal cytarabine
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Sweden1 site
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Gothenburg
About this study
Official title: Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol
- Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in high-risk ALL patients.
- Both acute and long-term toxicity are equal in both treatment arms.
Read the detailed description
20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.
The specific and primary objectives of the randomised study is:
- To replace intrathecal triple (methotrexate, cytarabine and glucocorticosteroid) by intrathecal liposomal cytarabine and glucocorticosteroid during maintenance therapy in order to decrease the central nervous system relapse rate in high-risk acute lymphoblastic leukemia patients.
- To evaluate acute and long-term toxicity in both treatment arms.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Liposomal cytarabine, Intrathecal triple
- Keywords
- Leukemia, Central nervous system, Neurotoxicity, Liposomal cytarabine, Children, Acute lymphoblastic leukemia, Childhood acute lymphoblastic leukemia, Intrathecal, Efficacy, Safety
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal cytarabineDrug
Also called Cytarbine, Ara-C, Cytosar-U, Cytosine arabinoside
Intrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL
Intrathecal tripleDrug
Also called DepoCyte, DepoCyt, Precortalon, Di-Adreson-F
Intrathecal methotrexate (8-12 mg), cytarabine (20 - 30 mg) and prednisolone sodium succinate (12,5 - 20 mg) 6 times during maintenance treatment in high-risk ALL protocol
| Study group | Role | What they receive |
|---|---|---|
| Liposomal cytarabine | Experimental | Intrathecal liposomal cytarabine (25 - 50 mg) combined with intrathecal prednisolone sodium succinate and oral dexamethasone 6 times during maintenance treatment for high-risk ALL Receives: Drug: Liposomal cytarabine |
| Intrathecal triple | Active comparator | Intrathecal methotrexate, cytarabine and prednisolone Receives: Drug: Intrathecal triple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of leukemia relapses in the central nervous system
Measured: 5 years
Secondary outcomes (1)
Neurological toxicity
Measured: 6 months after cessation of leukemia therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Sterility problems in DepoCyte production
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordic Society for Pediatric Hematology and Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Principal investigator, Arja Harila-Saari, Nordic Society for Pediatric Hematology and Oncology
- Investigators
- Arja Harila-Saari, MD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991744
- Sponsor's protocol ID
- NOPHOALL2008-DepoCyte
- Status last verified
- Oct 2012
- First submitted
- 7 Oct 2009
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol
- ClinicalTrials.gov ID
- NCT00991744
- Acronym / sponsor ID
- NOPHOALL2008-DepoCyte
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Leukemia, Central nervous system, Neurotoxicity, Liposomal cytarabine, Children, Acute lymphoblastic leukemia, Childhood acute lymphoblastic leukemia, Intrathecal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sterility problems in DepoCyte production
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nordic Society for Pediatric Hematology and OncologyUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- Jan 2009
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Oct 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.
- Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in high-risk ALL patients.
- Both acute and long-term toxicity are equal in both treatment arms.
Detailed description
20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.
The specific and primary objectives of the randomised study is:
- To replace intrathecal triple (methotrexate, cytarabine and glucocorticosteroid) by intrathecal liposomal cytarabine and glucocorticosteroid during maintenance therapy in order to decrease the central nervous system relapse rate in high-risk acute lymphoblastic leukemia patients.
- To evaluate acute and long-term toxicity in both treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal cytarabine | Experimental | Drug: Liposomal cytarabineIntrathecal liposomal cytarabine (25 - 50 mg) combined with intrathecal prednisolone sodium succinate and oral dexamethasone 6 times during maintenance treatment for high-risk ALL |
| Intrathecal triple | Active comparator | Drug: Intrathecal tripleIntrathecal methotrexate, cytarabine and prednisolone |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- High risk acute lymphoblastic leukemia
- Not eligible for bone marrow transplantation
- Age 1-18
- Written informed consent has been obtained
Key exclusion criteria (7 listed)
- Persistent NCI grade 3-4 neurotoxicity from previous treatments
- Bilineage ALL
- Leukemia predisposing syndromes (e.g. Downs syndrome, Ataxia Telangiectasia)
- Previous cancer
- Known intolerance to NOPHO ALL 2008 anticancer agents
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 |
|---|---|---|
| Liposomal cytarabineAlso: Cytarbine, Ara-C, Cytosar-U, Cytosine arabinosideIntrathecal liposomal cytarabine combined with intrathecal prednisolone and oral dexamethasone during maintenance treatment for high-risk ALL | Drug | Liposomal cytarabine |
| Intrathecal tripleAlso: DepoCyte, DepoCyt, Precortalon, Di-Adreson-FIntrathecal methotrexate (8-12 mg), cytarabine (20 - 30 mg) and prednisolone sodium succinate (12,5 - 20 mg) 6 times during maintenance treatment in high-risk ALL protocol | Drug | Intrathecal triple |
Primary outcome
Number of leukemia relapses in the central nervous system
Time frame: 5 years
1 secondary outcome
Neurological toxicity
Time frame: 6 months after cessation of leukemia therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
- Home page of NOPHO - most areas are closedLink 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.
Arja Harila-Saari, MD principal investigator
Oulu University Hospital
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal cytarabine and Intrathecal triple in people with Acute Lymphoblastic Leukemia, run by Nordic Society for Pediatric Hematology and Oncology at 5 sites in 5 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 4 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: paused, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Finland, Iceland, Norway, Sweden. 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?
Results are not available in the source record.
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 leukemia relapses in the central nervous system (time frame: 5 years). 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 10 Oct 2012.