A phase 3b, multi-center, open-label, treatment optimization study of oral asciminib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP) previously treated with 2 or more tyrosine kinase inhibitors

ovartis Farmacéutica S.A.0 sites186 target enrollmentJuly 27, 2021

Overview

No summary available.

Registry

who.int

Start Date

July 27, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ovartis Farmacéutica S.A.

•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
•Adequate end organ function (as per central laboratory tests)
•Other protocol defined inclusion criteria may apply.
•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 124
•F.1\.3 Elderly (\>\=65 years) yes

•Known presence of the BCR\-ABL1 T315I mutation at any time prior to study entry
•Known history of 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
•Other protocol defined exclusion criteria may apply