drugset / Trial / NCT00416598

Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia

NCT00416598

Phase 2 Completed 546 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.

Timeline

Start
2006-11-15
Primary completion
2011-01-31
Completion
2016-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Background Busulfan Small molecule Intravenous
Background Cytarabine Small molecule Intravenous
Background Daunorubicin Small molecule Intravenous
Background Etoposide Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous