Ma-Spore ALL 2020 Study
NCT06336395 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2024-03-28
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.
Conditions
- B Lymphoblastic Leukemia
Interventions
- DRUG
-
Prednisolone
Oral
- DRUG
-
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
-
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
-
Intravenous
- DRUG
-
Subcutaneous/ Intravenous
- DRUG
-
Mercaptopurine
Oral
- DRUG
-
Thioguanine
Oral
- DRUG
-
Intravenous
- DRUG
-
Doxorubicin
Intravenous
- DRUG
-
Intravenous
Sponsors & Collaborators
-
National University Hospital, Singapore
lead OTHER
Principal Investigators
-
Allen Eng Juh Yeoh, MBBS · Professor
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-04
- Primary Completion
- 2030-03-31
- Completion
- 2030-03-31
Countries
- Malaysia
- Singapore
Study Locations
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