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NCT03885830 · ClinicalTrials.gov registry record
Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients
A clinical trial of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, Chronic Phase, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- 45
- Enrollment target
- 1
- Study location
NCT03885830 is a study of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, Chronic Phase that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 45 participants, below the 209-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03885830, a study of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, Chronic Phase, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Dasatinib
- DRUG Bosutinib
- DRUG Nilotinib
- DRUG Imatinib
Study Locations (1)
North Carolina
- UNC Hospital - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2022-06-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03885830
The ClinicalTrials.gov registry entry for NCT03885830 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (78% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Dasatinib is the first listed.
NCT03885830 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT03885830 about?
NCT03885830 is a clinical study titled "Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients". 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 t...
What is the current status of trial NCT03885830?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2019-06-20. Estimated completion is 2022-06-15.
What conditions does trial NCT03885830 study?
This clinical trial studies the following conditions: Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic Phase, CML (Chronic Myelogenous Leukemia), CML, Chronic Phase, CML - Philadelphia Chromosome.
What interventions are being tested in trial NCT03885830?
The interventions under investigation include: Dasatinib (DRUG), Bosutinib (DRUG), Nilotinib (DRUG), Imatinib (DRUG).
Who is sponsoring clinical trial NCT03885830?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03885830 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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