Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients

Acute Lymphocytic Leukemia Clinical Trial

Official title:

Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021159
• Other study ID #: 141052
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determine P-glycoprotein expression in blood samples of Acute Lymphocytic leukemia (ALL) pediatric patients receiving MTX treatment and trace its ontogeny and compare it with its expression in pediatric healthy subjects. In addition, to determine the correlation of P-glycoprotein expression and Methotrexate concentration at steady state.

Description:

The 20 leukemic patients will be classified into three age groups according to the ages that will be available at the time of sample collection.

• All patients will be recruited from Tanta Oncology Center, Tanta University.

• The study will be approved by the Research Ethics Committee of Tanta University and college of Pharmacy ethical committee.

• An informed consent will be obtained from parents of all patients in this research before enrollment.

• All patients' data will be private and confidential. Any unexpected risks that may appear during the course of the research will be reported to patients and the ethical committee on time.

Blood Samples will be obtained from healthy pediatric subjects of the same ages of the diseased group subjects (Samples will be obtained from subjects from a primary care center during their routine blood analysis excluding patients of chronic diseases, patients receiving any medications, and patients of impaired kidney or liver functions).

P-glycoprotein expression will be estimated in all samples using Permeability glycoprotein (P-gp), ELISA Kit, and its expression will be traced with development from the youngest till the oldest age available, this will also be compared with normal healthy pediatric subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Pediatric Acute Lymphocytic Leukemia Patients

• aged < 18 years old

• who are already taking the ALL MTX protocol.

Exclusion Criteria:

• Severe renal impairment (eGFR< 30 mL/min/1.73 m2 at screening)

• Critically ill patients.

• Other types of cancer

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• MTX, (but the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression)
the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, Tanta University	Tanta	Gharbiya
Egypt	Tanta Cancer Center	Tanta	Gharbiya
Egypt	Tanta University	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Aller SG, Yu J, Ward A, Weng Y, Chittaboina S, Zhuo R, Harrell PM, Trinh YT, Zhang Q, Urbatsch IL, Chang G. Structure of P-glycoprotein reveals a molecular basis for poly-specific drug binding. Science. 2009 Mar 27;323(5922):1718-22. doi: 10.1126/science.1168750. — View Citation

Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med. 2003 Sep 18;349(12):1157-67. Review. — View Citation

Namanja HA, Emmert D, Davis DA, Campos C, Miller DS, Hrycyna CA, Chmielewski J. Toward eradicating HIV reservoirs in the brain: inhibiting P-glycoprotein at the blood-brain barrier with prodrug abacavir dimers. J Am Chem Soc. 2012 Feb 15;134(6):2976-80. doi: 10.1021/ja206867t. Epub 2011 Sep 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P-gp expression in blood samples	P-gp expression in blood samples	42 hours
Primary	Methotrexate concentration in blood samples	Methotrexate concentration in blood samples	42 hours