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Therapeutic Areas: Oncology | Hematology | Musculoskeletal
Disease Category: Leukemia
Location: United States, IL

Clinical Trial Details


Research Study Summary

S0919 - Phase II A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)


The purpose of this study is to find out what effects, good and/or bad, the combination of regular chemotherapy plus pravastatin has on you and your leukemia. The chemotherapy is made up of two drugs which are commonly used to treat your type of leukemia. These drugs are idarubicin and ara-c. Pravastatin is a drug that is usually used to treat high cholesterol. We would like to see whether adding pravastatin to the chemotherapy will have an effect on you and your leukemia. Since pravastatin is not usually used to treat leukemia, it will be considered investigational for this study.

Patient Inclusion Criteria:

  • Patients must have a previous morphologically confirmed diagnosis of acute myeloid leukemia (AML). Note: This protocol uses the WHO diagnostic criteria for AML (see Section 4.1). Patients with acute promyelocytic leukemia (APL, FAB, M3) or blastic transformation of chronic myelogeneous leukemia are not eligible.
  • Patients must have received at least one prior chemotherapy regimen for their AML and they may have received any type of chemotherapy. They must have achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), lasting at least three months with their last induction regimen and they must have relapsed after the last regimen. Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause. Refractory patients and patients who have received autologous or allogeneic stem cell transplantation are not eligible. Administration of hydroxyurea to control high WBC count prior to, during and after registration is permitted.

Patient Exclusion Criteria:

  • Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias. Either an echocardiogram or MUGA scan with an ejection fraction = 45% must be obtained within 28 days prior to registration. (Either method for measuring cardiac function is acceptable, however, the same scan must be used throughout treatment and follow-up to monitor the patient for cardiac toxicity.) If patient has symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration.

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Both Male and Female



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Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183145

Date Last Changed: July 17, 2013

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