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Busulfan Concentration in Saliva and Plasma, and Its Relationship With Salivary Changes and Mucositis in the Digestive Tract of Patients Submitted to Hematopoietic Stem Cell Transplantation

NCT03492749 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2021-05-11

No results posted yet for this study

Summary

Busulfan (Bu) has been widely used for the treatment of neoplastic and non-neoplastic hematological disturbances, with satisfactory results in terms of successful hematopoietic stem cell transplantation (HSCT). Individual monitoring of the Bu dosage, which is done by means of various blood sample collections, is necessary for the purpose of attaining ideal therapeutic levels and minimizing systemic toxicity. This procedure sometimes becomes costly to and uncomfortable for the patient. Saliva has been analyzed as a possible alternative fluid for this monitoring.

Conditions

  • Bone Marrow Disease

Interventions

DIAGNOSTIC_TEST

Saliva monitoring

The first objective of this project is to verify the feasibility of using the analysis of salivary concentration of BU during individual adjustments of this drug in the period that precedes HSCT

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-02-29
Completion
2020-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03492749 on ClinicalTrials.gov