Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

ClinicalTrials.gov ID

NCT02894645

Lead Sponsor

National University Hospital, SingaporeOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

500Estimated

Last Update Posted

Sep 30, 2016Estimated

Start Date

Oct 2008

Primary Completion Date

Oct 2018Estimated

Official Title

Ma-Spore ALL 2010 Study

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.

• Acute Lymphoblastic Leukemia (ALL)

• Prednisolone
• Dexamethasone
• L-Asparaginase
• Vincristine
• Methotrexate
• Daunorubicin
• Doxorubicin
• Cyclophosphamide
• Cytarabine
• 6-Mercaptopurine
• Thioguanine
• Fludarabine
• Imatinib

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

National University Hospital, SingaporeOTHER

flslhp@gmail.com

allen_yeoh@nuhs.edu.sg(+65) 6772 4406

tan.ah.moy01@singhealth.com.sg(+65) 63941039

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