Acute Lymphoblastic Leukemia (ALL)Phase 4NCT02894645
Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study
A Phase 4 study testing Prednisolone, Dexamethasone and L-Asparaginase in people with Acute Lymphoblastic Leukemia (ALL), run by National University Hospital, Singapore at 4 sites in 2 countries.
Trial summary
The overall objective of this study is to continue to improve the cure rate of childhood acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a multi-centre cooperative trial using a risk-stratified therapy based primarily on early response to therapy utilizing a simplified minimal residual… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL)
- What is being tested?
- Prednisolone, Dexamethasone and L-Asparaginase
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2008to Oct 2018
- Phase
- Phase 4
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of non-Burkitt B-lineage ALL
- 1 to 17 years of age (before 18th birthday)
- Renal function within normal range for age
- Liver function within normal range for age
- Able to participate in the full 2 years of treatment
Who cannot join
- Age less than one year or age greater than/equals to 18 years
- Previous treatment with cytotoxic agents or high-dose steroids
- Mixed phenotype acute leukemia (MPAL)
- ALL as secondary malignancy
- Abnormal renal or liver function
- Doubtful compliance or unable to afford full course of therapy
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Malaysia2 sites, 2 recruiting
- Recruiting
University of Malaya Medical Centre
Kuala Lumpur, 59100
Hany Arrifin, MBBS, +603 7949 6785, hany@ummc.edu.my
- Recruiting
Subang Jaya Medical Centre
Subang Jaya, 47500
Hai Peng Lin, MBBS, flslhp@gmail.com
Lee Lee Chan, MBBS, drchanleelee@gmail.com
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Allen Yeoh, MBBS, (+65) 6772 4406, allen_yeoh@nuhs.edu.sg
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Ah Moy Tan, MBBS, (+65) 63941039, tan.ah.moy01@singhealth.com.sg
About this study
Official title: Ma-Spore ALL 2010 Study
The overall objective of this study is to continue to improve the cure rate of childhood acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a multi-centre cooperative trial using a risk-stratified therapy based primarily on early response to therapy utilizing a simplified minimal residual disease (MRD-lite) platform.
Read the detailed description
The study was designed on the premise that a risk classification strategy combining clinical and genetic presenting features with molecular assessment of MRD should reduce both treatment-related toxicities and relapse risk.
The patient will be assigned to one of the 3 risk groups depending on his/her response to the treatment and special laboratory tests. There are no experimental drugs in this study. All the drugs used are standard established treatment for childhood ALL for the last 30 years. The difference in treatment is by changes in the frequency and dose of the chemotherapy drugs.
The overall study treatment lasts for about 2 years.
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Being tested
- Prednisolone, Dexamethasone, L-Asparaginase, Vincristine, Methotrexate
- 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.
PrednisoloneDrug
Oral
DexamethasoneDrug
Oral
L-AsparaginaseDrug
Intramuscular injection
VincristineDrug
Intravenous
MethotrexateDrug
Intrathecal/ Intravenous/ Oral
DaunorubicinDrug
Intravenous
DoxorubicinDrug
Intravenous
CyclophosphamideDrug
Intravenous
CytarabineDrug
Intravenous/ Subcutaneous injection
6-MercaptopurineDrug
Oral
ThioguanineDrug
Oral
FludarabineDrug
Intravenous
ImatinibDrug
Oral (For BCR-ABL ALL only)
| Study group | Role | What they receive |
|---|---|---|
| Standard Risk (SR) | Other | Not described Receives: Drug: Prednisolone; Drug: Dexamethasone; Drug: L-Asparaginase; Drug: Vincristine; Drug: Methotrexate; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: 6-Mercaptopurine; Drug: Thioguanine |
| Intermediate Risk (IR) | Other | Not described Receives: Drug: Prednisolone; Drug: Dexamethasone; Drug: L-Asparaginase; Drug: Vincristine; Drug: Methotrexate; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: 6-Mercaptopurine; Drug: Thioguanine |
| High risk (HR) | Other | Not described Receives: Drug: Prednisolone; Drug: Dexamethasone; Drug: L-Asparaginase; Drug: Vincristine; Drug: Methotrexate; Drug: Daunorubicin; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: 6-Mercaptopurine; Drug: Thioguanine; Drug: Fludarabine; Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
EFS was estimated from time of diagnosis to time of first event or of patient's last follow-up. Failure to achieve complete remission (CR), relapse, death in continuous remission from whatever cause, secondary leukemia and abandonment (absence from scheduled therapy for more than 6 weeks) were considered as events.
Measured: 5 years
Overall survival (OS)
OS was determined from diagnosis to time of death from any cause.
Measured: 5 years
Minimal residual disease (MRD) measurement
Measured: At time point of Day 33, week 8 and week 12
Secondary outcomes (2)
Number of participants with chemotherapy-related adverse events as assessed by CTCAE version 4.0
Measured: Through study completion, an average of 2 years
Dose intensity of chemotherapy during various phases of therapy
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startOct 2008
- Primary completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia (ALL)Studies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allen Yeoh, MBBS, Principal investigator, Ma-spore Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894645
- Sponsor's protocol ID
- Ma-Spore ALL 2010
- Status last verified
- Sep 2016
- First submitted
- 25 Aug 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ariffin H, Chiew EKH, Oh BLZ, Lee SHR, Lim EH, Kham SKY, Abdullah WA, Chan LL, Foo KM, Lam JCM, Chan YH, Lin HP, Quah TC, Tan AM, Yeoh AEJ. Anthracycline-Free Protocol for Favorable-Risk Childhood ALL: A Noninferiority Comparison Between Malaysia-Singapore ALL 2003 and ALL 2010 Studies. J Clin Oncol. 2023 Jul 10;41(20):3642-3651. doi: 10.1200/JCO.22.02347. Epub 2023 Jun 5.
PubMed 37276496Yeoh AEJ, Lu Y, Chin WHN, Chiew EKH, Lim EH, Li Z, Kham SKY, Chan YH, Abdullah WA, Lin HP, Chan LL, Lam JCM, Tan PL, Quah TC, Tan AM, Ariffin H. Intensifying Treatment of Childhood B-Lymphoblastic Leukemia With IKZF1 Deletion Reduces Relapse and Improves Overall Survival: Results of Malaysia-Singapore ALL 2010 Study. J Clin Oncol. 2018 Sep 10;36(26):2726-2735. doi: 10.1200/JCO.2018.78.3050. Epub 2018 Jul 25.
PubMed 30044693
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ma-Spore ALL 2010 Study
- ClinicalTrials.gov ID
- NCT02894645
- Acronym / sponsor ID
- Ma-Spore ALL 2010
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2018 (estimated)
- First posted
- 9 Sep 2016 (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 overall objective of this study is to continue to improve the cure rate of childhood acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a multi-centre cooperative trial using a risk-stratified therapy based primarily on early response to therapy utilizing a simplified minimal residual disease (MRD-lite) platform.
Detailed description
The study was designed on the premise that a risk classification strategy combining clinical and genetic presenting features with molecular assessment of MRD should reduce both treatment-related toxicities and relapse risk.
The patient will be assigned to one of the 3 risk groups depending on his/her response to the treatment and special laboratory tests. There are no experimental drugs in this study. All the drugs used are standard established treatment for childhood ALL for the last 30 years. The difference in treatment is by changes in the frequency and dose of the chemotherapy drugs.
The overall study treatment lasts for about 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Risk (SR) | Other | Drug: Prednisolone, Drug: Dexamethasone, Drug: L-Asparaginase, Drug: Vincristine, Drug: Methotrexate, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: 6-Mercaptopurine, Drug: Thioguanine |
| Intermediate Risk (IR) | Other | Drug: Prednisolone, Drug: Dexamethasone, Drug: L-Asparaginase, Drug: Vincristine, Drug: Methotrexate, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: 6-Mercaptopurine, Drug: Thioguanine |
| High risk (HR) | Other | Drug: Prednisolone, Drug: Dexamethasone, Drug: L-Asparaginase, Drug: Vincristine, Drug: Methotrexate, Drug: Daunorubicin, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: 6-Mercaptopurine, Drug: Thioguanine, Drug: Fludarabine, Drug: Imatinib |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Confirmed diagnosis of non-Burkitt B-lineage ALL
- 1 to 17 years of age (before 18th birthday)
- Renal function within normal range for age
- Liver function within normal range for age
- Able to participate in the full 2 years of treatment
Key exclusion criteria (6 listed)
- Age less than one year or age greater than/equals to 18 years
- Previous treatment with cytotoxic agents or high-dose steroids
- Mixed phenotype acute leukemia (MPAL)
- ALL as secondary malignancy
- Abnormal renal or liver function
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 |
|---|---|---|
| PrednisoloneOral | Drug | High risk (HR), Intermediate Risk (IR), Standard Risk (SR) |
| DexamethasoneOral | Drug | High risk (HR), Intermediate Risk (IR), Standard Risk (SR) |
| L-AsparaginaseIntramuscular injection | Drug | High risk (HR), Intermediate Risk (IR), Standard Risk (SR) |
| VincristineIntravenous | Drug | High risk (HR), Intermediate Risk (IR), Standard Risk (SR) |
| MethotrexateIntrathecal/ Intravenous/ Oral | Drug | High risk (HR), Intermediate Risk (IR), Standard Risk (SR) |
| DaunorubicinIntravenous | Drug | High risk (HR) |
| DoxorubicinIntravenous | Drug | High risk (HR), Intermediate Risk (IR) |
| CyclophosphamideIntravenous | Drug | High risk (HR), Intermediate Risk (IR), Standard Risk (SR) |
| CytarabineIntravenous/ Subcutaneous injection | Drug | High risk (HR), Intermediate Risk (IR), Standard Risk (SR) |
| 6-MercaptopurineOral | Drug | High risk (HR), Intermediate Risk (IR), Standard Risk (SR) |
| ThioguanineOral | Drug | High risk (HR), Intermediate Risk (IR), Standard Risk (SR) |
| FludarabineIntravenous | Drug | High risk (HR) |
| ImatinibOral (For BCR-ABL ALL only) | Drug | High risk (HR) |
Primary outcome
Event-free survival (EFS)
Time frame: 5 years
EFS was estimated from time of diagnosis to time of first event or of patient's last follow-up. Failure to achieve complete remission (CR), relapse, death in continuous remission from whatever cause, secondary leukemia and abandonment (absence from scheduled therapy for more than 6 weeks) were considered as events.
Overall survival (OS)
Time frame: 5 years
OS was determined from diagnosis to time of death from any cause.
Minimal residual disease (MRD) measurement
Time frame: At time point of Day 33, week 8 and week 12
2 secondary outcomes
Number of participants with chemotherapy-related adverse events as assessed by CTCAE version 4.0
Time frame: Through study completion, an average of 2 years
Dose intensity of chemotherapy during various phases of therapy
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Derived from this study: PubMed 37276496Ariffin H, Chiew EKH, Oh BLZ, Lee SHR, Lim EH, Kham SKY, Abdullah WA, Chan LL, Foo KM, Lam JCM, Chan YH, Lin HP, Quah TC, Tan AM, Yeoh AEJ. Anthracycline-Free Protocol for Favorable-Risk Childhood ALL: A Noninferiority Comparison Between Malaysia-Singapore ALL 2003 and ALL 2010 Studies. J Clin Oncol. 2023 Jul 10;41(20):3642-3651. doi: 10.1200/JCO.22.02347. Epub 2023 Jun 5.
- Derived from this study: PubMed 30044693Yeoh AEJ, Lu Y, Chin WHN, Chiew EKH, Lim EH, Li Z, Kham SKY, Chan YH, Abdullah WA, Lin HP, Chan LL, Lam JCM, Tan PL, Quah TC, Tan AM, Ariffin H. Intensifying Treatment of Childhood B-Lymphoblastic Leukemia With IKZF1 Deletion Reduces Relapse and Improves Overall Survival: Results of Malaysia-Singapore ALL 2010 Study. J Clin Oncol. 2018 Sep 10;36(26):2726-2735. doi: 10.1200/JCO.2018.78.3050. Epub 2018 Jul 25.
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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.
Allen Yeoh, MBBS principal investigator
Ma-spore Group
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone, Dexamethasone and L-Asparaginase in people with Acute Lymphoblastic Leukemia (ALL), run by National University Hospital, Singapore at 4 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 6 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: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Malaysia, Singapore. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Allen Yeoh, MBBS ((+65) 6772 4406, allen_yeoh@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: 5 years). The study lists 3 primary outcomes in all. 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 NCT02894645, which also lists 2 linked publications.
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 30 Sep 2016.