Trial · NCT03885830
Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients
NCT03885830, Completed, UNC Lineberger Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients. Trials, record NCT03885830. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03885830
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients
- NCT number
- NCT03885830
- Status
- Completed
- Enrollment
- 45 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- CML, Chronic Phase, CML (Chronic Myelogenous Leukemia, CML - Philadelphia Chromosome, Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic Phase
- Interventions
- Bosutinib, Dasatinib, Imatinib, Nilotinib
- First posted
- 2019-03-22
- Last updated
- 2023-01-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Correlation between TKI Exposure/Clearance and BCR-ABL transcript | 12 months | 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. |
| Secondary | Complete Hematologic Response (CHR) | 1 month | CHR at 1 month, defined as complete normalization of peripheral blood counts with leukocyte count \< 10 x 1E9/L, platelet count \< 450 x 1E9/L, no immature cells (such as myelocytes, promyelocytes, no blasts in peripheral blood, and no signs and symptoms of disease with disappearance of palpable splenomegaly. |
| Secondary | Correlation between Early Molecular Response (EMR) and TKI Exposure/Clearance | 3 months, 6 months | Incidence of EMR at 3 and 6 months, defined as BCR-ABL transcript ≤ 10%, will be evaluated, and will be compared against TKI levels at 3 and 6 months. |
| Secondary | Correlation between Major Molecular response (MMR) and TKI Exposure/Clearance | 9 months, 12 months | Incidence of MMR at 9 and 12 months, defined as BCR-ABL transcript ≤ 0.1%, will be evaluated, and will be compared against TKI levels at 9 and 12 months. |
| Secondary | Correlation between Log10 change in BCR-ABL and TKI Exposure/Clearance | Baseline and 1, 3, 6, 9, and 12 months | BCR-ABL transcripts will be obtained at each time point. The Log10 change in BCR-ABL transcripts will be evaluated, and will be compared against TKI levels at each time point. |
| Secondary | Medication Adherence | Baseline and 1, 3, 6, 9, and 12 months | Subject adherence will be evaluated at each time point during standard-of-care study visits. The Wilson's 3-item Adherence Score (WAS) tool will be administered to each subject at each visit in survey form. The WAS tool provides a score from 0-100 (0, worst; 100, best) to evaluate adherence to medications in the last 30 days. |
| Secondary | Correlation between Medication-induced Toxicities and TKi Exposure/Clearance | Baseline and 1, 3, 6, 9, and 12 months | Associate TKI exposure/clearance with subject-reported toxicity assessments. Medication-induced toxicity assessments will be conducted at each study visit using the validated MD Anderson Symptom Inventory for CML (MDASI-CML) tool. The MDASI-CML tool asks subjects to rate symptom severity in the last 24 hours on a 0-10 scale (0, not present; 10, as bad as one can imagine). The MDASI-CML also evaluates symptom interference with daily activities in the same manner. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03885830
GET https://conductscience.org/api/trials/v1/NCT03885830/registered