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RECRUITING
NCT03286634
PHASE2

ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

Sponsor: National Hospital Organization Nagoya Medical Center

View on ClinicalTrials.gov

Summary

To evaluate the outcome of a prednisolone and low dose methotrexate based protocol in Down syndrome children with ALL (DS-ALL) in an Asia-wide study. The treatment protocol was modified based upon backbone of Taiwan Pediatric Oncology Group (TPOG)-ALL protocol in which risk classification will be guided by level of flow minimal residual disease (MRD) instead.

Official title: Asia-wide, Multicenter Open-label, Phase II Non-randomised Study Involving Children With Down Syndrome Under 21 Year-old With Newly Diagnosed, Treatment naïve Acute Lymphoblastic Leukemia

Key Details

Gender

All

Age Range

0 Years - 20 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2017-04-18

Completion Date

2033-03-31

Last Updated

2022-09-28

Healthy Volunteers

No

Interventions

DRUG

Daunorubicin

Given IV

DRUG

Prednisolone

Given PO or IV

DRUG

Vincristine

Given IV

DRUG

Epirubicin

Given IV

DRUG

E-coli L-asparaginase

Given IM or IV

DRUG

6-Mercaptopurine

Given PO

DRUG

Methotrexate

Given IV, PO or IT

DRUG

Hydrocortisone

Given IT

DRUG

Cytarabine

Given IV, IT or SC

DRUG

Cyclophosphamide

Given IV

Locations (10)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Kagoshima University Hospital

Kagoshima, Japan

University of Malaya Medical Centre

Kuala Lumpur, Malaysia

Subang Jaya Medical Centre

Subang Jaya, Malaysia

National University Hospital

Singapore, Singapore

KK Women's and Children's Hospital

Singapore, Singapore

National Taiwan University Children's Hospital

Taipei, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Chang Gung Memorial Hopsital, Linkou

Taoyuan District, Taiwan

Siriraj Hospital Mahidol University

Bangkok, Thailand