Acute Lymphoblastic LeukemiaPhase 3ALL2008conNCT00816049
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy
A Phase 3 study testing 6MPindividualized and 6MPfixed in people with Acute Lymphoblastic Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in 5 countries.
Trial summary
The purpose of this study is to increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85. Read more about this study
- Who is it for?
- Ages 1 year to 45 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- 6MPindividualized and 6MPfixed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 775 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Jan 2009to 2 Mar 2016
- 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 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Childhood ALL
- All mandatory biological data are available6
- Written informed consent has been obtained
Who cannot join
- Mixed lineage ALL
- Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
- ALL predisposition syndromes
- Previous cancer
- Off protocol administration of additional chemotherapy during induction therapy
- Sexually active females not using contraception
- TPMT-deficiency
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Sweden2 sites
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Gothenburg
NOPHO nordic organisation for pediatric onology
Stockholm
About this study
Official title: Nordic Society of Paediatric Haematology and Oncology Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults (18-45 Years of Age) With ALL. Efficacy of Individualised 6MP Dosing During Consolidation Therapy
The purpose of this study is to increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85.
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 increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- 6MPindividualized, 6MPfixed
- Keywords
- acute lymphoblastic leukemia, child, 6-mercaptopurine, minimal residual disease, efficacy, childhood acute lymphoblastic leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6MPindividualizedDrug
Also called PuriNethol, Puri-Nethol (6-mercaptopurine)
Oral 6-mercaptopurine with a starting dose of 25 mg/m2 and upward adjusted in steps of 25 mg/m2 (i.e. 50 or 75 mg/m2) if unacceptable bone-marrox toxicity is not encountered
6MPfixedDrug
Also called PuriNethol, Puri-Nethol (6-mercaptopurine)
Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85
| Study group | Role | What they receive |
|---|---|---|
| 6MPfixed | Active comparator | Fixed dose 6-mercaptopurine days 30-85 Receives: Drug: 6MPfixed |
| 6MPindividualized | Experimental | Individualized dose increments of 6-mercaptopurine days 30-85 Receives: Drug: 6MPindividualized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of patients that become MRD-negative at treatment days 85 and/or 92 (end-of-consolidation) and event-free survival. MRD is measured either by Flow-cytometry (for PreB-ALL patients) or PCR for clonal generearrangements(for T-ALL patients)
Measured: 6 years
Secondary outcomes (1)
Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startJan 2009
- Primary completion2 Mar 2016
- Study completion2 Mar 2016
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 775 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Society for Pediatric Hematology and Oncology
- Responsible party
- Principal investigator, Kjeld Schmiegelow, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kjeld Schmiegelow, M.D., Study chair, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816049
- Sponsor's protocol ID
- NOPHO ALL2008 consolidation
- Acronym
- ALL2008con
- Status last verified
- Apr 2017
- First submitted
- 23 Dec 2008
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic Society of Paediatric Haematology and Oncology Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults (18-45 Years of Age) With ALL. Efficacy of Individualised 6MP Dosing During Consolidation Therapy
- ClinicalTrials.gov ID
- NCT00816049
- Acronym / sponsor ID
- ALL2008con / NOPHO ALL2008 consolidation
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- acute lymphoblastic leukemia, child, 6-mercaptopurine, minimal residual disease, efficacy, childhood acute lymphoblastic leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 775 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Nordic Society for Pediatric Hematology and Oncology
- Study start
- Jan 2009 (actual)
- Primary completion
- 2 Mar 2016 (actual)
- Study completion
- 2 Mar 2016 (actual)
- First posted
- 31 Dec 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.
The purpose of this study is to increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85.
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 increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6MPfixed | Active comparator | Drug: 6MPfixedFixed dose 6-mercaptopurine days 30-85 |
| 6MPindividualized | Experimental | Drug: 6MPindividualizedIndividualized dose increments of 6-mercaptopurine days 30-85 |
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Childhood ALL
- All mandatory biological data are available6
- Written informed consent has been obtained
Key exclusion criteria (7 listed)
- Mixed lineage ALL
- Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
- ALL predisposition syndromes
- Previous cancer
- Off protocol administration of additional chemotherapy during induction therapy
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 |
|---|---|---|
| 6MPindividualizedAlso: PuriNethol, Puri-Nethol (6-mercaptopurine)Oral 6-mercaptopurine with a starting dose of 25 mg/m2 and upward adjusted in steps of 25 mg/m2 (i.e. 50 or 75 mg/m2) if unacceptable bone-marrox toxicity is not encountered | Drug | 6MPindividualized |
| 6MPfixedAlso: PuriNethol, Puri-Nethol (6-mercaptopurine)Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85 | Drug | 6MPfixed |
Primary outcome
Fraction of patients that become MRD-negative at treatment days 85 and/or 92 (end-of-consolidation) and event-free survival. MRD is measured either by Flow-cytometry (for PreB-ALL patients) or PCR for clonal generearrangements(for T-ALL patients)
Time frame: 6 years
1 secondary outcome
Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.
Time frame: 6 years
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 21 Apr 2017.
- Home page of NOPHO - most areas are closedLink provided by the sponsor.
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Kjeld Schmiegelow, M.D. study chair
Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
6 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 6MPindividualized and 6MPfixed in people with Acute Lymphoblastic Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 6 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 3 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Denmark, Finland, Iceland, Norway. 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?
Fraction of patients that become MRD-negative at treatment days 85 and/or 92 (end-of-consolidation) and event-free survival. MRD is measured either by Flow-cytometry (for PreB-ALL patients) or PCR for clonal generearrangements(for T-ALL patients) (time frame: 6 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 21 Apr 2017.