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Recruiting NCT06336395

Ma-Spore ALL 2020 Study

Phase II Interventional B Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prednisolone, Dexamethasone, Vincristine, Methotrexate.
Who it may be relevant to
Registry conditions: B Lymphoblastic Leukemia. Basic parameters: up to 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia, Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Primary outcome measures

  • Overall survival (OS) [Time frame: 5 years from diagnosis]
Secondary outcome measures (1)
  • Event free survival (EFS) [Time frame: 5 years from diagnosis]

Eligibility criteria

Inclusion criteria

  • Has been diagnosed with B-lineage ALL as evidenced by:
  • BMA blasts > 20% AND
  • Leukemic process in the bone marrow, peripheral blood or any extra medullary tissue with confirmation of B-lymphoid differentiation by flow immunophenotyping or histopathologically
  • Age < 41 years of age at enrolment
  • Written informed consent obtained from patient or legally acceptable representative (LAR)

Exclusion criteria

  • T-lineage ALL
  • Down syndrome with ALL
  • History of previous malignancies or this ALL is a second malignancy
  • Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia
  • Mature B-cell leukemia/lymphoma
  • Any previous cytotoxic therapy (chemotherapy/radiotherapy/immunotherapy). Patient pre-treated with short term steroid (< 7 days of duration within last 1 month prior to ALL treatment start) may be enrolled after discussion and written approval from PI. These patients should be treated on at least intermediate arm.
  • Persistent renal dysfunction with creatinine more than upper limit of normal for age before start of induction therapy. Patients requiring temporary dialysis without persistent renal dysfunction can qualify.
  • Liver dysfunction with direct bilirubin > 10x upper normal limit for age.
  • Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy
  • Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Malaysia · 2 centers
  • Subang Jaya Medical Centre — Kuala Lumpur
  • University Malaya Medical Centre — Kuala Lumpur
Singapore · 1 center
  • KK Women's and Children's Hospital — Singapore

Identifiers

NCT: NCT06336395 · 2019/00888

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗