drugset / Trial / NCT02085408

Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT02085408

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, 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 more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.

Timeline

Start
2011-02-04
Primary completion
2021-02-22
Completion
2022-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 20 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 30 mg/m2 Intravenous
Comparator Cytarabine Small molecule 100 mg/m2 Intravenous
Comparator Cytarabine Small molecule 1500 mg/m2 Intravenous
Comparator Daunorubicin Small molecule 60 mg/m2 Intravenous
Subject Decitabine Small molecule 20 mg/m2 Intravenous