Ma-Spore ALL 2020 Study

Sponsor
National University Hospital, Singapore
Study ID
NCT06336395
Phase
PHASE2
Status
Recruiting
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Conditions

  • B Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
N/A - 40 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 4, 2020
Status verified
Mar 2024
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard risk (SR)
    1. No anthracycline throughout the treatment. 2. CNS consolidation using "Capizzi type" low dose methotrexate (LDMTX) x 2 courses to replace pre-existing high dose methotrexate (HDMTX) 2.5g #3/4
  • Experimental: Intermediate risk (IR)
    Those with CD20 ≥ 20% expression on diagnostic blasts by flow immunophenotyping will receive additional dose of rituximab on day 1 of each delayed intensification (DI) phases: phase III (2 courses) and V (1 course) for total 3 infusions
  • Experimental: High risk (HR)
    Provisional HR patients will be offered CAR-T cell immunotherapy or HSCT

Primary Outcome Measure

Overall survival (OS) [ Time Frame: 5 years from diagnosis ]

Central Contacts