Clinical Trial DRUG 1315-0001
- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- Principal Investigator
- Jessica Altman
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG 1315-0001
- The purpose of this research study is three-fold: to identify the maximum tolerated dose, that is, the highest dose of the study drug that does not cause unacceptable side effects; to obtain information on the safety and effectiveness in people given the study drug alone; and to measure and evaluate the behavior of the study drug in the blood.
- Participants in this study have relapsed or refractory acute myeloid leukemia (AML). AML is a condition that causes rapid growth of abnormal white blood cells that increase in the bone marrow and interfere with production of normal blood cells. People with AML may experience fatigue, shortness of breath, easy bruising and bleeding, and increased risk of infection. Refractory AML is defined as disease that is not responsive to initial anti-leukemia treatment, while relapsed AML is disease that recurs following an initial complete remission. This is a research study to test a new investigational drug. An investigational drug is one that is not approved by the FDA. This study drug has not been previously used in any people.
Some of the eligibility criteria include:
- Participants must have relapsed or refractory AML with at least one prior treatment for AML.
- Participants must be 18 or older.
- Description of Treatment
- The Study Drug Treatment Phase consists of infusions (IV injected into a vein) with the study drug once per week. Each cycle of study drug treatment is 2 weeks long and will include two infusions (Days 1 and 8 of each cycle), once per week. Study participants will receive these infusions until their disease progresses, they experience unacceptable side effects, or they want to terminate the treatment.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 24-Jun-16 10:32 PM
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