drugset / Trial / NCT01802333

Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia

NCT01802333

Phase 3 Completed 754 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cytarabine with or without vorinostat to see how well they work in treating younger patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells. It is not yet known which combination chemotherapy is more effective in treating acute myeloid leukemia.

Timeline

Start
2013-02-12
Primary completion
2017-06-15
Completion
2017-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule Intravenous
Subject Daunorubicin Small molecule Intravenous
Subject Idarubicin Small molecule Intravenous
Subject Vorinostat Small molecule Oral