A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Phase 3

Recruiting

Conditions: Leukemia
Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
10024324

Registration Number: NL-OMON51998

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 2

Inclusion Criteria

1. Male or female patients with newly (< 3 monhts) diagnosed CML-CP >= 18
years of age.
2. Diagnosis of CML-CP with cytogenetic confirmation of Philadelphia chromosome
3. ECOG performance status of 0, or 1.
4. Adequate end organ function

Exclusion Criteria

1. Previous treatment of CML with any other anticancer agents including
chemotherapy and/or biologic agents or prior stem cell transplant
2. Known cytopathologically confirmed CNS infiltration.
3. Impaired cardiac function or cardiac repolarization abnormality
4. History of acute pancreatitis within 1 year of prior to randomization or
medical history of chronic
pancreatitis.
5. Pregnancy, lactation, insufficient contraception for females of
childbearing potential .

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Major Molecular Response.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional efficacy parameters.<br /><br>Pharmacokinetic parameters (Cmax, Tmax, AUCtau, AUClast, CL/F).<br /><br>Safety parameters (type, frequency and severity of AEs, changes in lab values<br /><br>outside the pre-determined ranges, relevant ECG changes, vital signs and<br /><br>physical examination changes).<br /><br>Exploratory parameters (biomarkers, pharmacogenetics, healthcare resource<br /><br>utilization, questionnaires).</p><br>