Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Risk (SR) | Other |
| |
| Intermediate Risk (IR) | Other |
| |
| High risk (HR) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Overall survival (OS) | OS was determined from diagnosis to time of death from any cause. | 5 years |
| Minimal residual disease (MRD) measurement | At time point of Day 33, week 8 and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with chemotherapy-related adverse events as assessed by CTCAE version 4.0 | Through study completion, an average of 2 years | |
| Dose intensity of chemotherapy during various phases of therapy | Through study completion, an average of 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allen Yeoh, MBBS | Contact | (+65) 6772 4406 | allen_yeoh@nuhs.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Allen Yeoh, MBBS | Ma-spore Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya Medical Centre | Recruiting | Kuala Lumpur | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37276496 | Derived | 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. | |
| 30044693 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dexamethasone | Drug | Oral |
|
| L-Asparaginase | Drug | Intramuscular injection |
|
| Vincristine | Drug | Intravenous |
|
| Methotrexate | Drug | Intrathecal/ Intravenous/ Oral |
|
| Daunorubicin | Drug | Intravenous |
|
| Doxorubicin | Drug | Intravenous |
|
| Cyclophosphamide | Drug | Intravenous |
|
| Cytarabine | Drug | Intravenous/ Subcutaneous injection |
|
| 6-Mercaptopurine | Drug | Oral |
|
| Thioguanine | Drug | Oral |
|
| Fludarabine | Drug | Intravenous |
|
| Imatinib | Drug | Oral (For BCR-ABL ALL only) |
|
| Subang Jaya Medical Centre | Recruiting | Subang Jaya | 47500 | Malaysia |
|
| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
|
| KK Women's and Children's Hospital | Recruiting | Singapore | 229899 | Singapore |
|
| Derived |
| 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. |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D003907 | Dexamethasone |
| D001215 | Asparaginase |
| D014750 | Vincristine |
| D008727 | Methotrexate |
| D003630 | Daunorubicin |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D015122 | Mercaptopurine |
| D013866 | Thioguanine |
| C024352 | fludarabine |
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D010879 | Piperazines |
Not provided
Not provided