Asciminib treatment optimization in = 3rd line CML-CP
- Conditions
- Chronic Myelogenous Leukemia in chronic phase (CML-CP)MedDRA version: 21.0Level: LLTClassification code: 10009012Term: Chronic myelogenous leukemia Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-511381-36-00
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 205
Signed informed consent must be obtained prior to participation in the study, Male or female patients with a diagnosis of CML-CP = 18 years of age, Treatment with a minimum of 2 or more prior TKIs (i.e. imatinib, nilotinib, dasatinib, bosutinib, radotinib or ponatinib), Warning or failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2, Adequate end organ function (as per central laboratory tests)
Known presence of the BCR-ABL1 T315I mutation at any time prior to study entry, Known second chronic phase of CML after previous progression to AP/BC, Previous treatment with a hematopoietic stem-cell transplantation, Patient planning to undergo allogeneic hematopoietic stem cell transplantation, Uncontrolled cardiac repolarization abnormality, Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol, History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis, History of ongoing active acute or chronic liver disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method