Clinical trial NCT02894645: Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study
Official title: Ma-Spore ALL 2010 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Lymphoblastic Leukemia (ALL)
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: Minimal residual disease (MRD) measurement
timeFrame: At time point of Day 33, week 8 and week 12
Secondary outcomes:
measure: Number of participants with chemotherapy-related adverse events as assessed by CTCAE version 4.0
timeFrame: Through study completion, an average of 2 years
measure: Dose intensity of chemotherapy during various phases of therapy
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Subang Jaya
country: Malaysia
facility: Subang Jaya Medical Centre
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: Ma-spore Group
name: Allen Yeoh, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeoh AEJ, Lu Y, Chin WHN, Chiew EKH, Lim EH, Li Z, Kham SKY, Chan YH, Abdullah WA, Lin HP, Chan LL, Lam JCM, Tan PL, Quah TC, Tan AM, Ariffin H. Intensifying Treatment of Childhood B-Lymphoblastic Leukemia With IKZF1 Deletion Reduces Relapse and Improves Overall Survival: Results of Malaysia-Singapore ALL 2010 Study. J Clin Oncol. 2018 Sep 10;36(26):2726-2735. doi: 10.1200/JCO.2018.78.3050. Epub 2018 Jul 25.