RecruitingPhase 2NCT03286634

ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

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


Sponsor

National Hospital Organization Nagoya Medical Center

Enrollment

60 participants

Start Date

Apr 18, 2017

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 0 YearsMax Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a specialized treatment protocol for children and young adults with Down syndrome who have been newly diagnosed with a type of blood cancer called acute lymphoblastic leukemia (ALL), recognizing that people with Down syndrome may respond to cancer treatments differently than others. **You may be eligible if...** - You have Down syndrome (diagnosed clinically or genetically, including mosaic Down syndrome) - You have been newly diagnosed with ALL (acute lymphoblastic leukemia) - You are under 21 years old at the time of enrollment - You are in reasonably good overall health **You may NOT be eligible if...** - You have a second cancer - Your leukemia tests positive for the Philadelphia chromosome (a specific genetic change) or is a certain rare subtype (mature B-cell ALL or mixed phenotype) - You have previously received cancer chemotherapy (short-term steroids for less than 7 days are allowed) - You have severely impaired kidney or liver function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaunorubicin

Given IV

DRUGPrednisolone

Given PO or IV

DRUGVincristine

Given IV

DRUGEpirubicin

Given IV

DRUGE-coli L-asparaginase

Given IM or IV

DRUG6-Mercaptopurine

Given PO

DRUGMethotrexate

Given IV, PO or IT

DRUGHydrocortisone

Given IT

DRUGCytarabine

Given IV, IT or SC

DRUGCyclophosphamide

Given IV


Locations(10)

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

View Full Details on ClinicalTrials.gov

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NCT03286634


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