Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients

Completed

Conditions studied: CML, Chronic Phase, CML (Chronic Myelogenous Leukemia, CML - Philadelphia Chromosome, Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic Phase

In brief

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.

Key facts

Study ID

NCT03885830

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

45

Starts

2019-06-20

Expected to finish

2022-06-15

Last updated by the study team

2023-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
• Patients must be ≥ 18 years old.
• Patients must have been diagnosed with chronic phase CML.
• Patients who will start or have already started receiving oral chemotherapy with bosutinib, dasatinib, imatinib, or nilotinib for their diagnosis of CML.

You may not qualify if…

• Patients who have cognitive impairments that could affect informed decision making.
• Patients who are prescribed bosutinib, dasatinib, imatinib, or nilotinib in combination with other chemotheapy agents (e.g., hydroxyurea or omacetaxine).
• Patients who have undetectable BCR-ABL transcripts.
• Patients with a confirmed T315I point mutation in BCR-ABL and/or prescribed ponatinib.
• Patients who are incarcerated.
• Patients with accelerated or blast phase CML.
• Patients diagnosed with, or currently undergoing treatment for a concurrent second primary malignancy.

Where it is running

• UNC Hospital — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.