Membrane Target Detection for Leukemia Treatment

Hematological Malignancy Clinical Trial

Official title:

Tumor Cell and DNA Detection in the Peripheral Blood of Patients With Hematological Malignancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04841447
• Other study ID #: 2018932
• Status: Recruiting
• Start date: March 20, 2020
• Est. completion date: March 20, 2026

Study information

• Verified date: April 2023
• Source: University of Missouri-Columbia
• Contact: Xunlei Kang, MD.PhD
• Phone: 5738844524
• Email: kangxu[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 20, 2026
• Est. primary completion date: March 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Neoplasms

Intervention

Other:
• Study sample collection
Peripheral blood draws and bone marrow aspiration will be done during clinic visit and hospital stay.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DPP4 inhibitors measured in blood samples will be correlated with patient survival data.	DPP4 inhibitors measured in blood samples will be used in vitro and in vivo a pre-clinical model.	5 years