Membrane Target Detection for Leukemia Treatment

Sponsor
University of Missouri-Columbia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04841447
Collaborator
(none)
50
1
72
0.7

Study Details

Study Description

Brief Summary

Acute myeloid leukemia (AML) accounts for more than 40% of leukemia mortality in the United States. Each year around ten thousand people die from the disease, most within a few years of diagnosis. Despite advances in our understanding of the disease, few improvements in the therapy of AML have been made. Collecting specimens from the blood and bone marrow will increase understanding of the effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors on human AML-SCP to develop individualized therapies. We also found DPP4 is highly expressed in other hematological malignancies in our mouse model, thus we would like to use human samples to investigate the role of DPP4 in hematological malignancy development and the mechanism underlying, especially to deeply understand the role of DDP4 in leukemia.

Condition or Disease Intervention/Treatment Phase
  • Other: Study sample collection

Detailed Description

Specific targets and novel strategies to eliminate AML stem cells are required for AML treatment. Collecting specimens from the blood and bone marrow will increase understanding of the effect of DPP4 inhibitors on human AML-SCP to develop individualized therapies. We will test the effect of DPP4 inhibitors on human AML-SCP in vitro and in vivo and whether the addition of DPP4 inhibitors can prevent AML relapse once the disease is in the remission stage.

Chronic myeloid leukemia (CML) is a stem cell (SC) neoplasm characterized by the BCR/ABL1 oncogene. CML is a steadily developing blood and bone marrow disease that has three stages: chronic, accelerated, and blastic. If it reaches the blastic process, it is known as acute leukemia, which is the same as AML. While the mechanisms of BCR/ABL1-induced transformation are well understood, little is known about the effector molecules that contribute to leukemic SC (LSC) malignant expansion and extramedullary spread in CML. Furthermore, DPP4 is not only highly expressed in leukemia samples, but also specifically expressed in some of the other hematological malignancies, such as AML, CML, ALL, CLL, Lymphomas, or Myelomas, and may work as a stem cell marker as well. At this point, we would like to use human blood samples to investigate the role of DPP4 in hematological malignancy to deeply understand the role of DPP4 in leukemia.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tumor Cell and DNA Detection in the Peripheral Blood of Patients With Hematological Malignancy
Actual Study Start Date :
Mar 20, 2020
Anticipated Primary Completion Date :
Mar 20, 2025
Anticipated Study Completion Date :
Mar 20, 2026

Outcome Measures

Primary Outcome Measures

  1. DPP4 inhibitors measured in blood samples will be correlated with patient survival data. [5 years]

    DPP4 inhibitors measured in blood samples will be used in vitro and in vivo a pre-clinical model.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All hematological malignancy patients.

  • Must be 18 years old.

Exclusion Criteria:
  • Participants with impaired decision-making capacities;

  • Pregnant women or fetuses;

  • Children (under 18 in Missouri, also dependent on State law);

  • Non-viable neonates or neonates of uncertain viability (neonates=newborns);

  • Non-English-speaking subjects;

  • Prisoners.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Missouri Columbia Missouri United States 65212

Sponsors and Collaborators

  • University of Missouri-Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xunlei Kang, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT04841447
Other Study ID Numbers:
  • 2018932
First Posted:
Apr 12, 2021
Last Update Posted:
Dec 30, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2021