Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

NCT02894645 | Unknown Phase 4 DMC

• 1 other identifier: Ma-Spore ALL 2010
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 4

Brief 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 disease (MRD-lite) platform.

Conditions

Acute Lymphoblastic Leukemia (ALL)

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• 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

Study Arms (3)

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

Interventions

Prednisolone DRUG

Oral

High risk (HR); Intermediate Risk (IR); Standard Risk (SR)

Dexamethasone DRUG

Oral

High risk (HR); Intermediate Risk (IR); Standard Risk (SR)

L-Asparaginase DRUG

Intramuscular injection

High risk (HR); Intermediate Risk (IR); Standard Risk (SR)

Vincristine DRUG

Intravenous

High risk (HR); Intermediate Risk (IR); Standard Risk (SR)

Methotrexate DRUG

Intrathecal/ Intravenous/ Oral

High risk (HR); Intermediate Risk (IR); Standard Risk (SR)

Daunorubicin DRUG

Intravenous

High risk (HR)

Doxorubicin DRUG

Intravenous

High risk (HR); Intermediate Risk (IR)

Cyclophosphamide DRUG

Intravenous

High risk (HR); Intermediate Risk (IR); Standard Risk (SR)

Cytarabine DRUG

Intravenous/ Subcutaneous injection

High risk (HR); Intermediate Risk (IR); Standard Risk (SR)

6-Mercaptopurine DRUG

Oral

High risk (HR); Intermediate Risk (IR); Standard Risk (SR)

Thioguanine DRUG

Oral

High risk (HR); Intermediate Risk (IR); Standard Risk (SR)

Fludarabine DRUG

Intravenous

High risk (HR)

Imatinib DRUG

Oral (For BCR-ABL ALL only)

High risk (HR)

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed diagnosis of non-Burkitt B-lineage ALL
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (4)

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

Subang Jaya Medical Centre

Subang Jaya, 47500, Malaysia

RECRUITING

National University Hospital

Singapore, 119074, Singapore

RECRUITING

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

Related Publications (2)

• 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.

  PMID: 37276496 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.

  PMID: 30044693 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Prednisolone; Dexamethasone; Asparaginase; Vincristine; Methotrexate; Daunorubicin; Doxorubicin; Cyclophosphamide; Cytarabine; Mercaptopurine; Thioguanine; fludarabine; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Aminopterin; Pterins; Pteridines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds; Sulfur Compounds; Purines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Piperazines

Study Officials

• Allen Yeoh, MBBS

  Ma-spore Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allen Yeoh, MBBS

CONTACT

(+65) 6772 4406; allen_yeoh@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 9, 2016
• Study Start: October 1, 2008
• Primary Completion: October 1, 2018
• Last Updated: September 30, 2016

Record last verified: 2016-09

Locations

SG (2); MY (2)