NCT06336395

Ma-Spore ALL 2020 Study

Ma-Spore ALL-Seq 2020: RNA-Seq and IgH/TCR-Seq to Improve Risk Assignment in Childhood, Adolescent and Young Adult Acute Lymphoblastic Leukaemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy.

Detailed description

This is a multicenter open-label phase II study involving children and young adult (\< 41 years old) who are newly diagnosed with B-ALL and treatment naïve. There will be 3 parallel cohorts whose risk to be stratified based upon leukemia genetics profiles and patient's treatment response: 1. Standard Risk (SR) 2. Intermediate Risk (IR) 3. High Risk (HR) All drugs being used are commercially available chemotherapy drugs. There will be no novel chemotherapeutic agent without marketing authorization being tested in this trial.

Conditions

• B Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Prednisolone	Oral
DRUG	Dexamethasone	Oral
DRUG	Vincristine	Intravenous
DRUG	Methotrexate	Oral/ intrathecal/intravenous/subcutaneous
DRUG	L-Asparaginase	Intramuscular
DRUG	Pegylated asparaginase	Intravenous
DRUG	Erwinase	Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)
DRUG	Dasatinib	Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)
DRUG	Imatinib	Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)
DRUG	Cyclophosphamide	Intravenous
DRUG	Cytarabine	Subcutaneous/ Intravenous
DRUG	Mercaptopurine	Oral
DRUG	Thioguanine	Oral
DRUG	Rituximab	Intravenous
DRUG	Doxorubicin	Intravenous
DRUG	Fludarabine	Intravenous

Timeline

• Start date: 2020-03-04
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2024-03-28
• Last updated: 2024-03-28

Locations

3 sites across 2 countries: Malaysia, Singapore