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

  • End date
    Mar 31, 2033
  • participants needed
  • sponsor
    National Hospital Organization Nagoya Medical Center
Updated on 16 October 2022
lymphoid leukemia
minimal residual disease
residual tumor


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.

Condition Down Syndrome, Acute Lymphoblastic Leukemia, Childhood Cancer
Treatment cyclophosphamide, methotrexate, cytarabine, Epirubicin, vincristine, Daunorubicin, Prednisolone, Hydrocortisone, 6-mercaptopurine, E-coli L-asparaginase
Clinical Study IdentifierNCT03286634
SponsorNational Hospital Organization Nagoya Medical Center
Last Modified on16 October 2022


Yes No Not Sure

Inclusion Criteria

Down syndrome diagnosed clinically or cytogenetically (including Mosaic Down)
Newly diagnosed ALL according to WHO 2016 classification
Age < 21 years old at time of enrollment
ECOG performance status (PS) score of 0-2
Written informed consent obtained from legally acceptable representatives

Exclusion Criteria

Second malignancy
Philadelphia positive ALL
Mature B-ALL
Mixed phenotype acute leukemia
Any previous treatment with cytotoxic chemotherapy excluding treatment for TAM or radiation therapy. Patient pre-treated with short term steroid (< 7 days of duration within last 1 month prior to treatment start) can be enrolled into this study
Renal dysfunction with creatinine >2x upper limit of normal (ULN). Patients whose creatinine has improved to <2x ULN before treatment commencement can enrol subject to discretion of site PI
Liver dysfunction with direct bilirubin > 5x ULN
Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy, including
History of coronary arterial disease, cardiomyopathy, heart failure, arrhythmia (other than sinus arrhythmia) or severe cardiac malformation which with residual abnormalities or requires further major corrective surgery within 2 years
Ongoing uncontrolled hypertension
Ongoing uncontrolled diabetes mellitus
Ongoing uncontrolled infection
History of congenital or acquired immunodeficiency including HIV infection
History of interstitial pneumonia, pulmonary fibrosis, bronchiectasis or severe pulmonary emphysema
CNS hemorrhage
Psychiatric disorder
Other concurrent active neoplasms
Pregnant or lactating women
Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator
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