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ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016
Sponsor: National Hospital Organization Nagoya Medical Center
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
Daunorubicin
Given IV
Prednisolone
Given PO or IV
Vincristine
Given IV
Epirubicin
Given IV
E-coli L-asparaginase
Given IM or IV
6-Mercaptopurine
Given PO
Methotrexate
Given IV, PO or IT
Hydrocortisone
Given IT
Cytarabine
Given IV, IT or SC
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