Status:
COMPLETED
Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib Versus Best Available Therapy, Previously Treated With 2 or More Tyrosine Kinase Inhibitors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Leukemia, Chronic Myelogenous
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
The purpose of this Chinese bridging study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of asciminib versus best available therapy in Chinese patients with Chronic Myelogenou...
Detailed Description
The purpose of this Chinese bridging study is to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of asciminib versus best available therapy (BAT) in Chinese patients with Chronic...
Eligibility Criteria
Inclusion
- Diagnosed as CML-CP:
- Participants must meet all of the following laboratory values at the screening visit:
- \< 15% blasts in peripheral blood and bone marrow \< 30% blasts plus promyelocytes in peripheral blood and bone marrow \< 20% basophils in the peripheral blood
- 50 x 10\^9/ L (≥ 50,000/mm3) platelets Transient prior therapy related thrombocytopenia (\< 50,000/mm3 for ≤ 30 days prior to screening) is acceptable No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
- Prior treatment with a minimum of 2 prior ATP-competitive TKIs.
- Failure (adapted from the 2013 European Leukemia Net (ELN) Guidelines) or intolerance to the most recent TKI therapy at the time of screening.
- Evidence of typical BCR-ABL1 transcript \[e14a2 and/or e13a2\] at the time of screening which are amenable to standardized RQ-PCR quantification
Exclusion
- Known presence of the 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
- Participants planning to undergo allogeneic hematopoietic stem cell transplantation
- Cardiac or cardiac repolarization abnormality, including any of the following:
- History within 6 months prior to starting study treatment of myocardial infarction, angina pectoris, coronary artery bypass graft Clinically significant cardiac arrhythmias , complete left bundle branch block, high-grade AV block QTcF at screening ≥450 msec (male participants), ≥460 msec (female participants)
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- Risk factors for Torsades de Pointes including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia Concomitant medication(s) with a "Known risk of Torsades de Pointes" that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
- Inability to determine the QTcF interval
- History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
December 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04795427
Start Date
December 6 2021
End Date
November 18 2024
Last Update
April 18 2025
Active Locations (20)
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1
Novartis Investigative Site
Chongqing, Chongqing Municipality, China, 400010
2
Novartis Investigative Site
Guangzhou, Guangdong, China, 510515
3
Novartis Investigative Site
Shenzhen, Guangdong, China, 518037
4
Novartis Investigative Site
Zhengzhou, Henan, China, 450008