Active — Not RecruitingPhase 2

ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

Hong Kong, Japan, Malaysia60 participantsStarted 2017-04-18

Plain-language 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.

Who can participate

Age range0 Years – 20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.

What they're measuring

Event Free Survival

Timeframe: Up to 5 years

Trial details

NCT IDNCT03286634

SponsorNational Hospital Organization Nagoya Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

View on ClinicalTrials.gov More Down Syndrome trials