Clinical trial · Observational
A Study to Evaluate Available Treatment Information of Ponatinib, Bosutinib, Imatinib, Dasatinib and Nilotinib in Adults With Chronic Myeloid Leukemia
Evaluate the Real-World Safety Outcomes and Clinical Efficacy of Ponatinib and Other Tyrosine Kinase Inhibitors Among Chronic Myeloid Leukemia Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aims of this study are to learn out about treatment information (including amongst others treatment patterns, safety, development of a participant's condition) ponatinib, bosutinib, imatinib, dasatinib and nilotinib using already available data. No new data will be collected from participants as part of this study and no study medicines will be provided in this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Ponatinib Cohort
- description
- Participants will be classified into the cohorts based on the TKI (ponatinib, bosutinib, and others \[imatinib, dasatinib, or nilotinib\]) drug used on index date, stratified by prior TKI use. Participants with a ponatinib prescription identified as the index drug prior TKI use will be stratified in this cohort.
- interventionNames
- Other: No Intervention
- label
- Bosutinib Cohort
- description
- Participants will be classified into the cohorts based on the TKI (ponatinib, bosutinib, and others \[imatinib, dasatinib, or nilotinib\]) drug used on index date, stratified by prior TKI use. Participants without ponatinib use and with bosutinib identified as the index drug prior TKI use will be stratified in this cohort.
- interventionNames
- Other: No Intervention
- label
- Other TKI Cohort
- description
- Participants will be classified into the cohorts based on the TKI (ponatinib, bosutinib, and others \[imatinib, dasatinib, or nilotinib\]) drug used on index date, stratified by prior TKI use. Participants without ponatinib or bosutinib use and with imatinib, dasatinib, or nilotinib identified as the index drug after prior TKI use will be stratified in this cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: Participants will be included in the study if they: 1. had ≥1 prescription for TKI (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) from April 1, 2013-March 31, 2017; * For participants with ponatinib use, the first ponatinib prescription date will be defined as the index date; for participants with bosutinib but not ponatinib use, the first bosutinib prescription date will be defined as the index date; and for participants without ponatinib and bosutinib use, the first imatinib, dasatinib, nilotinib prescription date will be defined as the index date. * Participants with \>1 type of TKI on the index date will be dropped. 2. had ≥1 medical diagnosis for CML (International Classification of Diseases, Ninth Revision, Clinical Modification \[ICD-9-CM\]: 205.1; ICD-10-CM: C92.1) any time prior to the index date or within 6 months post-index date; diagnosis codes in the primary or secondary position will be used; the first CML diagnosis date will be designated as the initial CML diagnosis date; 3. were aged ≥18 years on the index date; 4. were active in the Humedica EMR data 6 months pre- and post-index date, indicated by the first and last healthcare activity in the data; * Participant data will be assessed until the earliest of switch to another TKI, disenrollment, death, or study end date. The minimum required duration of follow-up can be further revised based on the average duration of first-line treatment. * Participants who died in 6 months will be included. Exclusion criteria: Participants will be excluded from the study if they: 1. had ≥1 prescription for their index TKI (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) any time prior to the index date. 2. This will allow ≥6-month wash-out period, and ensure we are capturing second line participants.
References
Publications (0)
Data not yet available