NCT03286634

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Hospital Organization Nagoya Medical Center · Academic / Other
• Sex: All
• Age: 0 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Down Syndrome
• Acute Lymphoblastic Leukemia
• Childhood Cancer

Interventions

Type	Name	Description
DRUG	Daunorubicin	Given IV
DRUG	Prednisolone	Given PO or IV
DRUG	Vincristine	Given IV
DRUG	Epirubicin	Given IV
DRUG	E-coli L-asparaginase	Given IM or IV
DRUG	6-Mercaptopurine	Given PO
DRUG	Methotrexate	Given IV, PO or IT
DRUG	Hydrocortisone	Given IT
DRUG	Cytarabine	Given IV, IT or SC
DRUG	Cyclophosphamide	Given IV

Timeline

• Start date: 2017-04-18
• Primary completion: 2028-03-31
• Completion: 2033-03-31
• First posted: 2017-09-18
• Last updated: 2022-09-28

Locations

10 sites across 6 countries: Hong Kong, Japan, Malaysia, Singapore, Taiwan, Thailand