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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: Completed study of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, Chronic Phase, sponsored by UNC Lineberger Comprehensive Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
TKI exposure/clearance will be evaluated by measuring levels of TKI in the blood during the 12 month study period. BCR-ABL transcripts at 12 months will be compared against the TKI levels.
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 |
What the finished NCT03885830 record still lists
NCT03885830 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 209-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03885830's enrollment target sits among peer trials
45 22nd of 35 higher than 13 of 35 other Chronic Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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