Clinical trial NCT04841447: Membrane Target Detection for Leukemia Treatment
Official title: Tumor Cell and DNA Detection in the Peripheral Blood of Patients with Hematological Malignancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematological Malignancy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hematological malignancy patients.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: DPP4 inhibitors measured in blood samples will be correlated with patient survival data.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References: