Clinical trial · Observational
Pulmonary Vasculopathy Under Second-line Therapy of Chronic Myeloid Leukemia
Pulmonary Vascular Changes in Patients With Chronic Myeloid Leukemia With Second-line Therapy Dasatinib vs. Nilotinib
- 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)
Chronic myelogenous leukemia (CML) is a chronic myeloproliferative disorder characterized by a translocation between chromosome 9 and 22, leading to a pathogenic tyrosine kinase signal transduction protein. CML can be treated with tyrosine kinase inhibitors (TKIs), which inhibit BCR/ABL kinase, such as imatinib. In about 20% of CML patients who are treated by imatinib, a complete cytogenetic response cannot be achieved. The other two novel TKIs (dasatinib and nilotinib), achieve higher rates of complete cytogenetic response and they are proposed as second-line therapy for imatinib-resistant patients or for those who do not tolerate imatinib. Dasatinib inhibits BCR/ABL kinase in about \>300 times in vitro in more than imatinib and also inhibits several other kinases, including the Src family. Src tyrosine kinase is crucial for potassium channel function in human pulmonary arteries. Imatinib and nilotinib do not inhibit the Src. Incident cases of precapillary PH have been reported in patients who have CML treated with the dasatinib. Improvements were usually observed after withdrawal of dasatinib. This study is designed to identify incident cases of dasatinib-associated PH and describe pulmonary vascular changes induced by dasatinib. As comparison population will be patients who receive another second-line TKI (nilotinib).
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 |
|---|---|---|---|
| Echo, exercise echo, and if indicated, right heart catheter | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- chronic meloid leukemia
- description
- echo, exercise echo, and if indicated, right heart catheter
- interventionNames
- Other: Echo, exercise echo, and if indicated, right heart catheter
Primary outcomes (1)
- measure
- systolic pulmonary arterial pressure during exercise (50W)
- timeFrame
- at baseline
- description
- In patients who undergo stressechocardiography: systolic pulmonary arterial pressure (SPAP) at 50W will be measured and the comparison between patients under dasatinib and nilotinib therapy will be performed.
Secondary outcomes (3)
- measure
- peak VO2
- timeFrame
- At baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * patients with chronic myeloid leukemia under second-line therapy with dasatinib or nilotinib * written informed consent Exclusion Criteria: * Manifest pulmonary hypertension * significant pulmonary disease * Left-sided heart failure or diastolic compliance dysfunction + * Hemodynamic relevant valvular disease * Systemic arterial hypertension (at rest systolic \>150 mmHg, diastolic \> 90 mmHg, during exercise \> 220 mmHg) * Severe anemia * Uncontrolled supraventricular and ventricular arrhythmias * Myocardial infarction (within the last 12 months) * Pulmonary embolism (within the last 12 months) * Recent therapy changes (within the last 12 months) * Recent major surgeries (within the last 12 months) * For exercise tests: musculoskeletal diseases which may unable the exercise tests.
References
Publications (0)
Data not yet available