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Brief Title: ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016
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
Study ID: NCT03286634
Brief 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.
Detailed Description:
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
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, , Taiwan
Siriraj Hospital Mahidol University, Bangkok, , Thailand
Name: Allen Yeoh, MBBS
Affiliation: National University Hospital, Singapore
Role: PRINCIPAL_INVESTIGATOR