A phase IIIb, multi-center, open-label, treatment optimization study of oralasciminib in patients with Chronic Myelogenous Leukemia in chronic phase (CMLCP)previously treated with 2 or more tyrosine kinase inhibitors - CABL001A2302

ovartis Pharma AG0 sites205 target enrollmentApril 2, 2024

Overview

No summary available.

Registry

who.int

Start Date

April 2, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

Not specified