- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01805843
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
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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Graz, Østerrike, 8036
- Medical University of Graz, Division of Pulmonology
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
chronic meloid leukemia
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
systolic pulmonary arterial pressure during exercise (50W)
Tidsramme: at baseline
|
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.
|
at baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
peak VO2
Tidsramme: At baseline
|
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. |
At baseline
|
change of pulmonary arterial pressure
Tidsramme: between baseline and after 6 months
|
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.
|
between baseline and after 6 months
|
Pulmonary vascular resistance
Tidsramme: at baseline
|
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.
|
at baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 24-311 ex 10/11
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Kronisk myeloid leukemi
-
University of PennsylvaniaAktiv, ikke rekrutterendeAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi, refraktær | Akutt myeloid leukemi, pediatriskForente stater
-
Betta Pharmaceuticals Co., Ltd.Har ikke rekruttert ennåAkutt Myeloid Leukemi LeukemiKina
-
Washington University School of MedicineTilbaketrukketRefraktær Akutt Myeloid Leukemi | Tilbakefallende akutt myeloid leukemiForente stater
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.AvsluttetAkutt myeloid leukemi | Refraktær Akutt Myeloid Leukemi | Tilbakefallende akutt myeloid leukemiForente stater
-
Peking University People's HospitalBeijing JD Biotech Co. LTD.RekrutteringAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi refraktærKina
-
Xuzhou Medical UniversityRekrutteringAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi refraktærKina
-
Bio-Path Holdings, Inc.RekrutteringAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi refraktærForente stater
-
Xuzhou Medical UniversityRekrutteringAkutt myeloid leukemi, i tilbakefall | Akutt myeloid leukemi refraktærKina
-
Children's Oncology GroupNational Cancer Institute (NCI)FullførtBarndom Akutt Myeloid Leukemi/Andre Myeloid MaligniteterForente stater
-
Ascentage Pharma Group Inc.Suzhou Yasheng Pharmaceutical Co., Ltd.RekrutteringStudie av APG2575 enkeltmiddel og kombinasjon med terapi hos pasienter med tilbakefall/refraktær AMLMyeloid malignitet | Tilbakefallende/Refraktær Akutt Myeloid LeukemiKina