Prospective Pilot Study of Bone Marrow and Peripheral Blood Samples From AML Patients to Characterize the Biologic Heterogeneity of the Disease Using Single Cell Network Profiling (SCNP)

Completed

Conditions studied: Acute Myeloid Leukemia

In brief

Treatment options and clinical outcomes for acute myeloid leukemia (AML) have not improved for more than 40 years. AML patients are still suffering from receiving costly, ineffective chemotherapy treatments with very high chances of bad side effects. The purpose of this study is to take a look at leukemia cells to see if the investigators can learn what makes them up and makes them aggressive and hard to treat. We want to use this information to create new treatments that the investigators hope are more effective and less harmful for AML patients. Newly diagnosed, relapsed or refractory (post induction therapy) AML patients that are 18 years of age or older will have bone marrow and blood samples taken for their regular AML treatment. When these tests are done during their treatment the investigators will need to get some extra blood and bone marrow to do this research. The patients will not be asked to have an extra needle stick or bone marrow biopsy to get these samples. The patients will have the same number of blood and bone marrow tests whether they participate in this study or not. We will only need to get about two teaspoons of blood and two teaspoons of bone marrow each time the patient has these tests during their regular AML treatment. The research the investigators do with these sample will not decide or change the care the patients get for their AML.

Key facts

Study ID

NCT01203033

Run by

West Virginia University

People needed

68

Starts

2010-09-01

Expected to finish

2012-10-01

Last updated by the study team

2017-02-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed, relapsed, or refractory (post induction therapy) AML patients age > 18
• For relapsed AML patients, previous treatment regimens received do not limit their eligibility to this study
• Patients enrolled will have no limitation as to the type of treatment they receive for their disease.
• Patient is able to give consent

You may not qualify if…

• AML-M3 patients
• AML patients age < 18
• AML patients in clinical remission
• AML patients who will not be able to receive diagnostic blood and marrow work up for any reason
• Patients who received allogeneic stem cell transplantation or autologous stem cell transplantation

Where it is running

• MBRCC, West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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