New hope for kids with down syndrome and leukemia: asia-wide study tests tailored chemo

NCT ID NCT03286634

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2017

Expected to finish

Mar 2033

An estimate. End dates often move.

Lead sponsor

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

0 to 20 years

Sex

Anyone

Healthy volunteers

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

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

  • Chang Gung Memorial Hopsital, Linkou

    Taoyuan, 333, Taiwan

  • KK Women's and Children's Hospital

    Singapore, 229899, Singapore

  • Kagoshima University Hospital

    Kagoshima, 890-8544, Japan

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • National Taiwan University Children's Hospital

    Taipei, 100, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • Prince of Wales Hospital

    Shatin, New Territories, Hong Kong

  • Siriraj Hospital Mahidol University

    Bangkok, 10700, Thailand

  • Subang Jaya Medical Centre

    Subang Jaya, 47500, Malaysia

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

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