Clinical trial · Observational
Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib
Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib. An Observational Multicentric Study.
- 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 GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases. The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.
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 |
|---|---|---|---|
| Dasatinib discontinuation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CML patients
- interventionNames
- Behavioral: Dasatinib discontinuation
Primary outcomes (1)
- measure
- Number of dasatinib permanent discontinuing patients.
- timeFrame
- After 2 years from study entry.
- description
- The cumulative rate of dasatinib permanent discontinuation by 2 years.
Secondary outcomes (18)
- measure
- Number of dasatinib permanent discontinuing patients.
- timeFrame
- After 5 years from study entry.
- description
- The cumulative rate of dasatinib permanent discontinuation by 5 years.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytogenetic and/or molecular confirmed diagnosis of Ph+ and/or BCR-ABL+ CML; Age 18 years; * Early chronic phase, less than 6 months from diagnosis. Prior treatment with Hydroxyurea or Anagrelide is allowed; * Signed written informed consent according to ICH/EU/GCP and national local laws prior to any study procedures. Exclusion Criteria: * Prior treatment with any protein tyrosin-kinase inhibitor (TKI) or interferon; * Recommendations and precautions before allocating a new CML case to dasatinib are fully described in the prescribing information.
References
Publications (0)
Data not yet available