| 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 