S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
Completed · Phase 2
Conditions studied: Leukemia
In brief
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia (AML). ADDITIONAL BACKGROUND: S0919 was initially designed for patients with relapsed acute myeloid leukemia (AML), where the patient's preceding remission had lasted ≥ 3 months. The null response rate was 30%. The study closed to accrual on Nov 1, 2012 after meeting the defined criterion for a positive study; and the results are being submitted to the American Society of Clinical Oncology meeting. Based on the promising results from this trial, the trial has now been amended to evaluate this therapeutic regimen in poor-risk patients (patients with newly diagnosed acute myeloid leukemia (AML) arising out of myelodysplastic syndrome (MDS), primary refractory acute myeloid leukemia (AML), and relapsed acute myeloid leukemia (AML) with the patient's preceding remission lasting \< 6 months).
Key facts
- Study ID
- NCT00840177
- Run by
- SWOG Cancer Research Network
- People needed
- 115
- Starts
- 2009-12-10
- Expected to finish
- 2021-10-21
- Last updated by the study team
- 2023-05-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Stanford Cancer Institute — Palo Alto, California, United States
- University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
- Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States
- Kootenai Medical Center — Coeur d'Alene, Idaho, United States
- Walter Knox Memorial Hospital — Emmett, Idaho, United States
- Idaho Urologic Institute-Meridian — Meridian, Idaho, United States
- Saint Alphonsus Medical Center-Nampa — Nampa, Idaho, United States
- Kootenai Cancer Center — Post Falls, Idaho, United States
- Kootenai Cancer Clinic — Sandpoint, Idaho, United States
- Saint Joseph Medical Center — Bloomington, Illinois, United States
- Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
- Illinois CancerCare-Canton — Canton, Illinois, United States
- Memorial Hospital of Carbondale — Carbondale, Illinois, United States
- SIH Cancer Institute — Carterville, Illinois, United States
- Illinois CancerCare-Carthage — Carthage, Illinois, United States
- Centralia Oncology Clinic — Centralia, Illinois, United States
- Cancer Care Center of Decatur — Decatur, Illinois, United States
- Decatur Memorial Hospital — Decatur, Illinois, United States
- Crossroads Cancer Center — Effingham, Illinois, United States
- Illinois CancerCare-Eureka — Eureka, Illinois, United States
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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