Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study
NCT ID: NCT02894645
Last Updated: 2016-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
500 participants
INTERVENTIONAL
2008-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Risk (SR)
Prednisolone
Oral
Dexamethasone
Oral
L-Asparaginase
Intramuscular injection
Vincristine
Intravenous
Methotrexate
Intrathecal/ Intravenous/ Oral
Cyclophosphamide
Intravenous
Cytarabine
Intravenous/ Subcutaneous injection
6-Mercaptopurine
Oral
Thioguanine
Oral
Intermediate Risk (IR)
Prednisolone
Oral
Dexamethasone
Oral
L-Asparaginase
Intramuscular injection
Vincristine
Intravenous
Methotrexate
Intrathecal/ Intravenous/ Oral
Doxorubicin
Intravenous
Cyclophosphamide
Intravenous
Cytarabine
Intravenous/ Subcutaneous injection
6-Mercaptopurine
Oral
Thioguanine
Oral
High risk (HR)
Prednisolone
Oral
Dexamethasone
Oral
L-Asparaginase
Intramuscular injection
Vincristine
Intravenous
Methotrexate
Intrathecal/ Intravenous/ Oral
Daunorubicin
Intravenous
Doxorubicin
Intravenous
Cyclophosphamide
Intravenous
Cytarabine
Intravenous/ Subcutaneous injection
6-Mercaptopurine
Oral
Thioguanine
Oral
Fludarabine
Intravenous
Imatinib
Oral (For BCR-ABL ALL only)
Interventions
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Prednisolone
Oral
Dexamethasone
Oral
L-Asparaginase
Intramuscular injection
Vincristine
Intravenous
Methotrexate
Intrathecal/ Intravenous/ Oral
Daunorubicin
Intravenous
Doxorubicin
Intravenous
Cyclophosphamide
Intravenous
Cytarabine
Intravenous/ Subcutaneous injection
6-Mercaptopurine
Oral
Thioguanine
Oral
Fludarabine
Intravenous
Imatinib
Oral (For BCR-ABL ALL only)
Eligibility Criteria
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Inclusion Criteria
2. 1 to 17 years of age (before 18th birthday)
3. Renal function within normal range for age
4. Liver function within normal range for age
5. Able to participate in the full 2 years of treatment
Exclusion Criteria
2. Previous treatment with cytotoxic agents or high-dose steroids
3. Mixed phenotype acute leukemia (MPAL)
4. ALL as secondary malignancy
5. Abnormal renal or liver function
6. Doubtful compliance or unable to afford full course of therapy
1 Year
17 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Allen Yeoh, MBBS
Role: PRINCIPAL_INVESTIGATOR
Ma-spore Group
Locations
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University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Subang Jaya Medical Centre
Subang Jaya, , Malaysia
National University Hospital
Singapore, , Singapore
KK Women's and Children's Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Hany Arrifin, MBBS
Role: primary
Hai Peng Lin, MBBS
Role: primary
Lee Lee Chan, MBBS
Role: backup
Allen Yeoh, MBBS
Role: primary
Ah Moy Tan, MBBS
Role: primary
References
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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.
Yeoh 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.
Other Identifiers
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Ma-Spore ALL 2010
Identifier Type: -
Identifier Source: org_study_id