Asciminib combination in chronic phase CM

Phase 1

• Conditions: Chronic Myeloid Leukemia; MedDRA version: 21.0Level: LLTClassification code 10009700Term: CMLSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-002256-33-DE
• Lead Sponsor: Friedrich-Schiller-Universität Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 77

Exclusion Criteria

• Allogeneic stem cell transplantation
• Known impaired cardiac function, including any of the following:
o Congenital long QT syndrome
o History of or presence of clinically significant ventricular or atrial tachyarrhythmia
o QTc >450 msec on screening ECG
o 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified