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)

NCT01203033 | Completed DMC

• 1 other identifier: WVU 1910
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemia; single cell network profiling; AML; SCNP

Outcome Measures

Primary Outcomes (2)

• 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

• To "bridge" assay performance between fresh and cryopreserved bone marrow and peripheral blood samples from AML patients.

  3 years

Study Arms (1)

AML patients

newly diagnosed or relapsed AML patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed or relapsed AML patients at the Mary Babb Randolph Cancer Center

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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

MBRCC, West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• William Tse, MD

  WVUCI - Mary Babb Randolph Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)