drugset / Trial / NCT02521493

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

NCT02521493

Phase 3 Active not recruiting 280 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

Timeline

Start
2015-12-23
Primary completion
2024-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Asparaginase Erwinia chrysanthemi Protein / enzyme biologic Intramuscular
Subject Cytarabine Small molecule Intrathecal
Subject Daunorubicin Small molecule
Subject Etoposide Small molecule Intravenous
Subject Mitoxantrone Small molecule Intravenous
Subject Thioguanine Small molecule Oral
Subject asparaginase Protein / enzyme biologic Intramuscular