Clinical trial · Observational
Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients
NCT05021159CI-TRIAL-00053668completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Methotrexate Group
- description
- 20 acute lymphocytic leukemia patients receiving MTX treatment (3- 5 mg/ cm2)
- interventionNames
- 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)
- label
- Healthy control group
- description
- 20 healthy pediatric subjects not receiving any treatment
Primary outcomes (2)
- measure
- P-gp expression in blood samples
- timeFrame
- 42 hours
- description
- P-gp expression in blood samples
- measure
- Methotrexate concentration in blood samples
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDAller 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
- BACKGROUNDNamanja 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
- RESULTKearns 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