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
Find Related Clinical Trials
Browse by Disease Sites
Other Clinical Trials by Jessica Altman
- A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
- A Phase IIa, Multicenter, Open-Label Study Designed to Evaluate the Safety and Efficacy of Escalating Doses of BL-8040 in Adult Subjects with Relapsed/Refractory Acute Myeloid Leukemia
- A Phase 1 Study of CSL362 (Anti-IL3Ra / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse
- A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Relapsed/Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic Malignancies
- A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients with Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
- A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
last updated: 06-Jul-15 07:16 PM
Clinical trial availability changes frequently. Please check this site often for updates or call 312.695.1102 for personal assistance.