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NCT03885830
Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients
trial testing Bosutinib in CML, Chronic Phase in 45 participants. Completed in 15 June 2022.
15 June 2022
Quick facts
| Lead sponsor | UNC Lineberger Comprehensive Cancer Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 45 |
| Start date | 20 June 2019 |
| Primary completion | 15 June 2022 |
| Estimated completion | 15 June 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Bosutinib (bosutinib) — full drug profile →
- Dasatinib (dasatinib) — full drug profile →
- Imatinib — full drug profile →
- Nilotinib (NILOTINIB) — full drug profile →
Conditions studied
- CML, Chronic Phase — all drugs for CML, Chronic Phase →
- CML (Chronic Myelogenous Leukemia — all drugs for CML (Chronic Myelogenous Leukemia →
- CML - Philadelphia Chromosome — all drugs for CML - Philadelphia Chromosome →
- Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →
Sponsor
UNC Lineberger Comprehensive Cancer Center — full company profile →
Who can join
18 and older, any sex, with CML, Chronic Phase or CML (Chronic Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacology of tyrosine kinase inhibitors in chronic myeloid leukemia; a clinician's perspective.
Pushpam D, Bakhshi S. · · 2020 · cited 14× · PMID 31900888 · DOI 10.1007/s40199-019-00321-z
Verify or expand the search:
- PubMed search for NCT03885830
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bosutinib
Trials testing the same drug.
- NCT04877522 — Asciminib Roll-over Study · Phase 4 · recruiting
- NCT05032690 — Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Or · Phase 1 · completed
- NCT05363488 — Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland · completed
- NCT04971226 — A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP · Phase 3 · active not recruiting
- NCT05286528 — Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of · completed
Other recruiting trials for CML, Chronic Phase
Currently open trials in the same condition.
- NCT05367700 — A Study of HS-10382 in Patients With Chronic Myeloid Leukemia. · Phase 1 · recruiting
- NCT03459534 — A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs · Phase 3 · recruiting
Other UNC Lineberger Comprehensive Cancer Center trials
Trials by the same sponsor.
- NCT06656936 — The PharmFIT Study · NA · not yet recruiting
- NCT05937659 — Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT · not yet recruiting
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- NCT07069595 — PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease · Phase 2 · recruiting
- NCT04266730 — Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03885830 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
- Last refreshed: 11 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03885830.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing