Clinical trial · Observational
Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib
Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib PCR-Monitoring, Adherence, Quality of Life, Therapy Satisfaction
- 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)
CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to prior therapies including Imatinib. Although Imatinib has demonstrated unprecedented efficacy in clinical trials, mostly in chronic phase CML, there is lack of published data on how CML is managed in real-life clinical practice settings. Therefore this non-interventional study is designed to collect real-life data on CML-treatment with Dasatinib in clinical routine with respect to first and second line treatment and/or switch setting (within 1st line or from 1st line TKI to 2nd line Dasatinib). Emphasis lies on health care provided in registered doctor's practices as here most of CML patients who are not involved in clinical trials are treated.
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 |
|---|---|---|---|
| Myeloid Leukemia, Chronic, Chronic-Phase | Myeloid Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Distribution of Molecular remission status at study entry and after 12 months.
- timeFrame
- 12 Months
- description
- Patients included into this study are on a treatment with Dasatinib. Fraction of BCR-ABL positive cells is measured at study entry or was assessed at the timepoint of Dasatinib treatment begin and classified as \>MR3, MR3, MR4, and MR4.5 as an ordinal measure. Molecular Fraction of BCR-ABL positive cells is reassessed after 12 months.
Secondary outcomes (15)
- measure
- Distribution of Molecular remission status at study entry and after 24 months.
- timeFrame
- 24 months
- description
- Patients included into this study are on a treatment with Dasatinib. Fraction of BCR-ABL positive cells is measured at study entry or was assessed at the time point of Dasatinib treatment begin and classified as \>MR3, MR3, MR4, and MR4.5 as an ordinal measure. Molecular Fraction of BCR-ABL positive cells is reassessed after 24 months.
- measure
- Best possible response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed CP-CML and CML patients in chronic phase resistant or intolerant to prior therapies, including Imatinib. Any line treatment of chronic CML. * 18 years or older at time of diagnosis * Receiving treatment with Dasatinib according to the SmPC * Written informed consent obtained before any screening procedure and according to local guidelines Exclusion Criteria: •Patients who are participating in a clinical trial for CML treatment will be excluded
References
Publications (0)
Data not yet available