New hope for kids with down syndrome and leukemia: asia-wide study tests tailored chemo
NCT ID NCT03286634
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study is testing a chemotherapy plan specially designed for children with Down syndrome who have a new diagnosis of acute lymphoblastic leukemia (ALL). The treatment uses lower doses of certain drugs to reduce side effects while still fighting the cancer. About 60 children across Asia are taking part, and researchers will track how many stay cancer-free for 5 years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2017
- Expected to finish
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Mar 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 20 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chang Gung Memorial Hopsital, Linkou
Taoyuan, 333, Taiwan
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KK Women's and Children's Hospital
Singapore, 229899, Singapore
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Kagoshima University Hospital
Kagoshima, 890-8544, Japan
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Mackay Memorial Hospital
Taipei, 10449, Taiwan
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National Taiwan University Children's Hospital
Taipei, 100, Taiwan
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National University Hospital
Singapore, 119074, Singapore
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Prince of Wales Hospital
Shatin, New Territories, Hong Kong
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Siriraj Hospital Mahidol University
Bangkok, 10700, Thailand
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Subang Jaya Medical Centre
Subang Jaya, 47500, Malaysia
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University of Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
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