Deutsches Leukämie-Studienregister
Studie: Fascination

Kurzübersicht
Öffentlicher Titel Phase II Studie zu Asciminib bei CML in chronischer Phase
Wissenschaftl. Titel Frontline Asciminib Combination in Chronic Phase CML
Kurztitel Fascination
Studiennummer KN/ELN LN_CMLSTU_2019_653
Studiengruppe CML-Studiengruppe
Studienphase Phase II
Erkrankung Chronische myeloische Leukämie (CML) - Chronische Phase
Molekularer Marker BCR-ABL
Einschlusskriterien
  • Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of the Ph+ chromosome [t(9;22)(q34;q11)].
  • Ph-negative cases or patients with variant translocations who are BCR-ABL1 positive in multiplex PCR 35 will be also considered eligible.
  • ECOG performance status of <=2.
  • Age >= 18 years old (no upper age limit is given)
  • Serum levels of potassium, magnesium, total calcium within the normal limits (>=LLN [lower limit of normal] and <=ULN [upper limit of normal]). Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed.
  • AST and ALT <=2.5 x ULN or 5.0 x ULN if considered due to leukemia
  • Alkaline phosphatase <=2.5 x ULN unless considered due to leukemia
  • Total bilirubin <=1.5 x ULN, except known Gilbert disease
  • Serum creatinine <=2 x ULN
  • Written informed consent prior to any study procedures being performed
Ausschlusskriterien
  • Allogeneic stem cell transplantation
  • Known impaired cardiac function, including any of the following:
  • 1. Congenital long QT syndrome
  • 2. History of or presence of clinically significant ventricular or atrial tachyarrhythmia
  • 3. QTc >450 msec on screening ECG
  • 4. Myocardial infarction within 12 months prior to starting therapy
  • Other clinical significant heart disease (e.g. unstable angina, congestive heart failure)
  • Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores >6), even if controlled
  • Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol
  • Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery)
  • Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4
  • Patients who have undergone major surgery <=2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study start. Post-menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential. Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 2 weeks following discontinuation of study drug
  • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
  • Known serious hypersensitivity reactions to asciminib, imatinib, nilotinib or dasatinib
  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
  • Patients unwilling or unable to comply with the protocol
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 10.10.2019
Studienleiter/in Ernst, PD Dr. med. habil., Thomas
Kurzprotokoll Kurzprotokoll
Sponsoren Friedrich-Schiller-Universität Jena
Förderer Novartis Pharma AG
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT03906292 (primäres Register)
European Clinical Trials Database - EUDRACT 2018-002256-33
erstellt 02.12.2019 Zenawit Krüger
geändert 02.12.2019 Zenawit Krüger
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