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Therapeutic Areas: Oncology | Hematology | Musculoskeletal
Disease Category: Leukemia
Location: United States, IL
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.
Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
1425 North Randall Road
Elgin, IL 60123
Research Center Information: Sherman Health
If you would like to learn more about participating in this study, please send an email message using the form below.
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