Status:
COMPLETED
Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy, su...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the rate of achieving a "good complete response (CR)" after treating patients with newly diagnosed acute myeloid leukemia (AML) with idarubicin, cytarabine and pravas...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of acute myeloid leukemia by World Health Organization (WHO) 2008 criteria, including patients with \>= 20% blasts in the bone marrow or peripheral blood (except acute promyelocytic leukemia), or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative neoplasm with \>= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) CMML-2 by WHO 2008 classification
- Untreated AML or high-risk myelodysplastic syndrome (MDS) and a simplified TRM score of =\< 9.2
- Bilirubin \< 2.0 mg/ml
- Any creatinine value is acceptable
- Any performance status is eligible
- Life expectancy otherwise \> 1 year
- Patients are not excluded based on cardiac history
- Females of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
- Patients must use an effective contraceptive method during the study and for a minimum of 90 days after study treatment
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01831232
Start Date
May 1 2013
End Date
January 1 2016
Last Update
November 17 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109