Clinical trial · Observational
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
NCT01244750CI-TRIAL-00059415SIMPLICITYcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.
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 |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- First line TKI treatment: Imatinib
- description
- Diagnosed CML patients who receive first line TKI treatment: Imatinib
- label
- First line TKI treatment: Nilotinib
- description
- Diagnosed CML patients who receive first line TKI treatment: Nilotinib
- label
- First line TKI treatment: Dasatinib
- description
- Diagnosed CML patients who receive first line TKI treatment: Dasatinib
- label
- Imatinib treated patients
- description
- Imatinib treated patients if their study index date is between January 2, 2008 and September 30, 2010
Primary outcomes (5)
- measure
- The rate of Complete Cytogenetic Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or nilotinib in accordance with the timelines below * 18 years or older at time of of CP-CML diagnosis a) Imatinib Cohorts * Patients who started their first-line Imatinib treatment between January 2, 2008 and September 30, 2010.Patients fitting this criterion are defined as retrospective Imatinib patients * Patients who started their first-line Imatinib treatment on or after October 1, 2010 b) Dasatinib Cohort * Patients who started their first-line Dasatinib treatment after the drug was approved in this indication c) Nilotinib Cohort * Patients who started their first-line Nilotinib treatment after the drug was approved in this indication * Patients are also eligible when they have already switched to a subsequent therapy (TKI or other) at the time of enrollment, as long as their first-line and subsequent CML treatment information is available at site for data entry into the study Electronic Case Report Form (eCRF) * Receiving treatment at medical practice (eg. community-based, office-based, hospital-based, academic setting, oncology center) Exclusion Criteria: * Patients who are participating in an interventional trial which may influence the management of their CML disease will be excluded Discontinuation Criteria: * Enrolled patients who join an interventional trial which may influence the management of their CML disease will be excluded at the time of entry into the interventional trial
References
Publications (1)
- DERIVEDHehlmann R, Cortes JE, Zyczynski T, Gambacorti-Passerini C, Goldberg SL, Mauro MJ, Michallet M, Simonsson B, Williams LA, Gajavelli S, DeGutis I, Sen GP, Paquette RL. Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY. Am J Hematol. 2019 Jan;94(1):46-54. doi: 10.1002/ajh.25306. Epub 2018 Oct 31. PMID 30290003