drugset / Trial / NCT02894645

Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

NCT02894645 ↗

Phase 4 Unknown 500 enrolled National University Hospital, Singapore
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-10
Primary completion
2018-10
Completion
—

Outcome

Met primary endpoint

paper the hazard ratio for MS2010-SR EFS was 0.98 (95% CI, 0.84 to 1.14; P = .79), confirming noninferiority. PMID 37276496 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Cytarabine Small molecule — Intravenous
Subject Daunorubicin Small molecule — Intravenous
Subject Dexamethasone Small molecule — Oral
Subject Doxorubicin Other / unclassified — Intravenous
Subject Fludarabine Small molecule — Intravenous
Subject Imatinib Small molecule — Oral
Subject L-asparaginase Protein / enzyme biologic — Intramuscular
Subject MERCAPTOPURINE ANHYDROUS Small molecule — Oral
Subject Methotrexate Small molecule — Intrathecal
Subject Prednisolone Other / unclassified — Oral
Subject Thioguanine Small molecule — Oral
Subject Vincristine Small molecule — Intravenous