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Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients

NCT03885830 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2023-01-11

No results posted yet for this study

Summary

The purpose of this prospective, single-institution observational study is to evaluate associations between the pharmacokinetic (PK) parameters for tyrosine kinase inhibitors (TKIs) used to treat chronic phase chronic myeloid leukemia (CML) and clinical outcomes for up to 12 months. The study aims to identify associations between TKI clearance and/or exposure with demographic and clinical patient characteristics, CML milestones, medication toxicities, medication adherence, and germline genetic variants.

Because this is an observational study, standard-of-care therapy will not be altered during the course of participation. Blood samples will be collected at each study visit (up to 6 visits) over the course of 12 months to evaluate TKI concentrations, and PK parameters. Blood will also be collected during the first visit to isolate DNA for next generation sequencing (NGS). Demographic information will be collected at baseline, while clinical and medication adherence information will be collected at baseline and then throughout the study.

There will be no direct benefit to you for your participation. Risks are minor, but could include bruising, vein irritation, lightheadedness/dizziness, and/or infection from blood draws, as well as potential loss of confidentiality.

Conditions

  • CML, Chronic Phase
  • CML (Chronic Myelogenous Leukemia
  • CML - Philadelphia Chromosome
  • Chronic Myeloid Leukemia
  • Chronic Myeloid Leukemia, Chronic Phase

Interventions

DRUG

Bosutinib

Subjects will be enrolled into this group if they are receiving bosutinib per standard of care. This is an observational study and no interventions will be made.

DRUG

Dasatinib

Subjects will be enrolled into this group if they are receiving dasatinib per standard of care. This is an observational study and no interventions will be made.

DRUG

Imatinib

Subjects will be enrolled into this group if they are receiving imatinib per standard of care. This is an observational study and no interventions will be made.

DRUG

Nilotinib

Subjects will be enrolled into this group if they are receiving nilotinib per standard of care. This is an observational study and no interventions will be made.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Daniel Crona, PharmD, PhD · University of North Carolina, Chapel Hill

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2022-06-15
Completion
2022-06-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03885830 on ClinicalTrials.gov