Ma-Spore ALL 2020 Study

Last updated: March 21, 2024
Sponsor: National University Hospital, Singapore
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Treatment

Dexamethasone

Cyclophosphamide

Pegylated asparaginase

Clinical Study ID

NCT06336395
2019/00888
  • Ages < 40
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. T-lineage ALL
  2. Down syndrome with ALL
  3. History of previous malignancies or this ALL is a second malignancy
  4. Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia
  5. Mature B-cell leukemia/lymphoma
  6. Any previous cytotoxic therapy (chemotherapy/radiotherapy/immunotherapy). Patientpre-treated with short term steroid (< 7 days of duration within last 1 month prior toALL treatment start) may be enrolled after discussion and written approval from PI.These patients should be treated on at least intermediate arm.
  7. Persistent renal dysfunction with creatinine more than upper limit of normal for agebefore start of induction therapy. Patients requiring temporary dialysis withoutpersistent renal dysfunction can qualify.
  8. Liver dysfunction with direct bilirubin > 10x upper normal limit for age.
  9. Any serious uncontrolled medical condition or impending end organ dysfunction thatwould impair the ability of the subject to receive protocol therapy
  10. Doubtful compliance or ability to complete study therapy due to financial, social,familial or geographic reason, or in the judgement of site investigator

Study Design

Total Participants: 500
Treatment Group(s): 16
Primary Treatment: Dexamethasone
Phase: 2
Study Start date:
March 04, 2020
Estimated Completion Date:
March 31, 2030

Study 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.

Connect with a study center

  • Subang Jaya Medical Centre

    Kuala Lumpur, 47500
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • KK Women's and Children's Hospital

    Singapore, 229899
    Singapore

    Active - Recruiting

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