Acute Myeloid Leukemia Clinical Trial
Official title:
Prospective Pilot Study of Bone Marrow and Peripheral Blood Samples From Acute Myeloid Leukemia (AML) Patients to Characterize the Biologic Heterogeneity of the Disease Using Single Cell Network Profiling (SCNP)
Verified date | February 2017 |
Source | West Virginia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | October 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | MBRCC, West Virginia University | Morgantown | West Virginia |
Lead Sponsor | Collaborator |
---|---|
West Virginia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To characterize the biologic phenotypes of leukemic blast cells in bone marrow and peripheral blood samples collected from AML patients during the natural history of the disease. | 3 years | ||
Primary | To "bridge" assay performance between fresh and cryopreserved bone marrow and peripheral blood samples from AML patients. | 3 years |
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