Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Status unconfirmed · Phase 3 · Has a placebo group
Conditions studied: Leukemia
In brief
The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.
Key facts
- Study ID
- NCT00651261
- Run by
- Alliance for Clinical Trials in Oncology
- People needed
- 717
- Starts
- 2008-04-01
- Last updated by the study team
- 2021-08-18
Who can join
Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- University of California Davis Cancer Center — Sacramento, California, United States
- Aurora Presbyterian Hospital — Aurora, Colorado, United States
- Boulder Community Hospital — Boulder, Colorado, United States
- Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
- St. Anthony Central Hospital — Denver, Colorado, United States
- Porter Adventist Hospital — Denver, Colorado, United States
- Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
- St. Joseph Hospital — Denver, Colorado, United States
- Rose Medical Center — Denver, Colorado, United States
- CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
- Swedish Medical Center — Englewood, Colorado, United States
- North Colorado Medical Center — Greeley, Colorado, United States
- Sky Ridge Medical Center — Lone Tree, Colorado, United States
- Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
- McKee Medical Center — Loveland, Colorado, United States
- North Suburban Medical Center — Thornton, Colorado, United States
- Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
- Helen and Harry Gray Cancer Center at Hartford Hospital — Hartford, Connecticut, United States
- Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States
- CCOP - Christiana Care Health Services — Newark, Delaware, United States
- University of Florida Shands Cancer Center — Gainesville, Florida, United States
- Memorial Cancer Institute at Memorial Regional Hospital — Hollywood, Florida, United States
- Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
- UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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