An observational study in Chronic Myeloid Leukemia, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2015-09-09.
Sponsored by Medical University of Graz · Observational
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).
Doppler echocardiography at rest will be performed in each patient. Patients without exercise capacity limitation an exercise test (Doppler echocardiography with spiroergometry) will be performed. Patients who show elevated SPAP at rest or during exercise (in this study SPAP ≥ 40 mmHg) or with reduced exercise capacity (peak VO2 \< 75%) a right heart catheterization (RHC) will be suggested. Additionally for the evaluation of exercise capacity a 6 MWD will be performed. This work- up of patients allows clinical and hemodynamic evaluation.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 16 is below the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 97 are open to participants now.
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patients with chronic myeloid leukemia under second-line therapy with dasatinib or nilotinib,
Exclusion Criteria:
echo, exercise echo, and if indicated, right heart catheter
Other: Echo, exercise echo, and if indicated, right heart catheter
routine echocardiography and special measurements of the right heart are performed at rest and during exercise
systolic pulmonary arterial pressure during exercise (50W)
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.
Time frame: at baseline
peak VO2
Mean PAP at rest, mPAP at 50W, peak VO2, 6 minute walk distance (6MWD), N terminal pro brain natriuretic peptide (NT-proBNP) at "dasatinib" vs."nilotinib" patients. Changes of SPAP at 50 W, pulmonary vascular resistance (PVR) at rest, changes of mPAP at rest and at 50W, peak VO2, 6 MWD, NT-pro BNP- in patients with dasatinib and nilotinib between the baseline and 6 months after.
Time frame: At baseline
change of pulmonary arterial pressure
Changes of SPAP at 50 W, pulmonary vascular resistance (PVR) at rest, changes of mPAP at rest and at 50W, peak VO2, 6 MWD, NT-pro BNP- in patients with dasatinib and nilotinib between the baseline and 6 months after.
Time frame: between baseline and after 6 months
Pulmonary vascular resistance
In patients who undergo a RHC: pulmonary vascular resistance (PVR) at rest will be measured and the comparison of patients with dasatinib and nilotinib therapy will be performed.
Time frame: at baseline
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Medical University of Graz