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

NCT05021159 | Completed

• 1 other identifier: 141052
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Acute Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (2)

• P-gp expression in blood samples

  P-gp expression in blood samples

  42 hours

• Methotrexate concentration in blood samples

  Methotrexate concentration in blood samples

  42 hours

Study Arms (2)

Methotrexate Group

20 acute lymphocytic leukemia patients receiving MTX treatment (3- 5 mg/ cm2)

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)

Healthy control group

20 healthy pediatric subjects not receiving any treatment

Interventions

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) OTHER

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

Methotrexate Group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric Acute Lymphocytic Leukemia Patients aged \< 18 years old who are already taking the ALL MTX protocol.

You may qualify if:

• Pediatric Acute Lymphocytic Leukemia Patients
• aged \< 18 years old
• who are already taking the ALL MTX protocol.

You may not qualify if:

• Severe renal impairment (eGFR\< 30 mL/min/1.73 m2 at screening)
• Critically ill patients.
• Other types of cancer

Sponsors & Collaborators

• Tanta University: lead

Study Sites (3)

Faculty of Pharmacy, Tanta University

Tanta, Gharbia Governorate, 31111, Egypt

Location

Tanta Cancer Center

Tanta, Gharbia Governorate, 31111, Egypt

Location

Tanta University

Tanta, Gharbia Governorate, 31111, Egypt

Location

Related 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.

  PMID: 19325113 BACKGROUND

• 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.

  PMID: 21866921 BACKGROUND

• 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. doi: 10.1056/NEJMra035092. No abstract available.

  PMID: 13679531 RESULT

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yasmine M Elmorsi, Msc

  Assistant lecturer in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University

  PRINCIPAL INVESTIGATOR

• Osama M Ibrahim, Professor

  Professor in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University

  STUDY CHAIR

• Tarek M Mostafa, Professor

  Assistant Professor in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: March 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

EG (3)