drugset
drugset / Trial / NCT03286634

ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

NCT03286634 ↗

Phase 2 Active not recruiting 60 enrolled National Hospital Organization Nagoya Medical Center
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-04-18
Primary completion
2028-03-31
Completion
2033-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Cytarabine Small molecule — Intravenous
Subject Daunorubicin Small molecule — Intravenous
Subject asparaginase Protein / enzyme biologic — Intramuscular
Background Epirubicin Small molecule — Intravenous
Background Hydrocortisone Other / unclassified — Intrathecal
Background MERCAPTOPURINE ANHYDROUS Small molecule — Oral
Background Methotrexate Small molecule — Intravenous
Background Prednisolone Other / unclassified — Oral
Background Vincristine Small molecule — Intravenous

Indications

Down syndrome acute lymphoblastic leukemia childhood malignant neoplasm