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

First listed
Mar 28, 2024
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