Ma-Spore ALL 2020 Study

NCT06336395 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-03-28

No results posted yet for this study

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

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06336395 on ClinicalTrials.gov