Clinical trial · Observational
LEONIDAS: Quality of Life Study in Chronic Myeloid Leukemia Patients
Mid to Long-term Quality of Life Effects Of imatiNIb Versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS)
NCT02164903CI-TRIAL-00034147QoL-CML0713unknownClinicalTrials.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 broad goal of this study is to investigate if differences exist (and in which areas and of what magnitude) in QoL and symptoms of patients with CML being treated with first line therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an additional objective is to characterize medication-taking behavior associated with imatinib or dasatinib.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QoL Survey Booklet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Imatinib
- description
- Patients in first line treatment with imatinib for no more than 3 years.
- interventionNames
- Other: QoL Survey Booklet
- label
- Dasatinib
- description
- Patients in first line treatment with dasatinib for no more than 3 years.
- interventionNames
- Other: QoL Survey Booklet
Primary outcomes (1)
- measure
- Severity of the impact of therapy on daily life in patients with CP-CML being treated with first line therapy with dasatinib and those receiving first line therapy with imatinib.
- timeFrame
- 24 months.
- description
- (outcome measure: European Organization for Research and EORTC QLQ-CML24 "Impact on daily life" scale)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older at the time of study entry; * Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis; * At least in CCyR (as documented by chromosome banding analysis of marrow cell metaphases) or in MMR (≤0.1% BCR-ABL IS) * CP-CML Patients in first line treatment with either dasatinib or imatinib for no more than 3 years; * Written informed consent. Exclusion Criteria: * Major cognitive deficits or psychiatric problems hampering a self-reported evaluation. * Not speaking and reading the language of the participating country. * Having received any CML treatment prior to therapy with imatinib or dasatinib for more than three months.
References
Publications (0)
Data not yet available
No reference posted for this study.