Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

Last updated: September 29, 2016
Sponsor: National University Hospital, Singapore
Overall Status: Trial Status Unknown

Phase

4

Condition

Leukemia (Pediatric)

Leukemia

Treatment

N/A

Clinical Study ID

NCT02894645
Ma-Spore ALL 2010
  • Ages 1-17
  • All Genders

Study Summary

The overall objective of this study is to continue to improve the cure rate of childhood acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a multi-centre cooperative trial using a risk-stratified therapy based primarily on early response to therapy utilizing a simplified minimal residual disease (MRD-lite) platform.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed diagnosis of non-Burkitt B-lineage ALL

  2. 1 to 17 years of age (before 18th birthday)

  3. Renal function within normal range for age

  4. Liver function within normal range for age

  5. Able to participate in the full 2 years of treatment

Exclusion

Exclusion Criteria:

  1. Age less than one year or age greater than/equals to 18 years

  2. Previous treatment with cytotoxic agents or high-dose steroids

  3. Mixed phenotype acute leukemia (MPAL)

  4. ALL as secondary malignancy

  5. Abnormal renal or liver function

  6. Doubtful compliance or unable to afford full course of therapy

Study Design

Total Participants: 500
Study Start date:
October 01, 2008
Estimated Completion Date:

Study Description

The study was designed on the premise that a risk classification strategy combining clinical and genetic presenting features with molecular assessment of MRD should reduce both treatment-related toxicities and relapse risk.

The patient will be assigned to one of the 3 risk groups depending on his/her response to the treatment and special laboratory tests. There are no experimental drugs in this study. All the drugs used are standard established treatment for childhood ALL for the last 30 years. The difference in treatment is by changes in the frequency and dose of the chemotherapy drugs.

The overall study treatment lasts for about 2 years.

Connect with a study center

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • Subang Jaya Medical Centre

    Subang Jaya, 47500
    Malaysia

    Active - Recruiting

  • KK Women's and Children's Hospital

    Singapore, 229899
    Singapore

    Active - Recruiting

  • National University Hospital

    Singapore, 119074
    Singapore

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.