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Clinical Trials in Taiwan / NCT03286634
Active, not recruiting Phase 2

ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

NCT03286634 · tracked via the Priya Life Science Taiwan tracker
Sponsor
National Hospital Organization Nagoya Medical Center
Phase
Phase 2
Started
2017-04-18
Last updated
2026-05-11

Condition(s) studied

Down SyndromeAcute Lymphoblastic LeukemiaChildhood Cancer

Investigational drug(s) / intervention(s)

Daunorubicin →Prednisolone →Vincristine →Epirubicin →E-coli L-asparaginase6-Mercaptopurine →Methotrexate →Hydrocortisone →Cytarabine →Cyclophosphamide →

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

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
20 Years
Healthy volunteers
No
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: 1. 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. 2. Ongoing uncontrolled hypertension. 3. Ongoing uncontrolled diabetes mellitus. 4. Ongoing uncontrolled infection. 5. History of congenital or acquired immunodeficiency including HIV infection. 6. History of interstitial pneumonia, pulmonary fibrosis, bronchiectasis or severe pulmonary emphysema. 7. CNS hemorrhage. 8. Psychiatric disorder. 9. 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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Prince of Wales Hospital Shatin New Territories
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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03286634 on ClinicalTrials.gov ↗ ← All trials in Taiwan