CompletedPhase 2

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

China84 participantsStarted 2021-12-06

Plain-language 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 Myelogenous Leukemia in chronic phase, previously treated with 2 or more tyrosine kinase inhibitors to support related indication registration in China. The primary objective of the study is to evaluate the Major Molecular Response (MMR) rate of asciminib treatment at 24 weeks.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Participants must meet all of the following laboratory values at the screening visit:
✓. 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 criteria

✕. 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 of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis

What they're measuring

Major molecular response rate of asciminib

Timeframe: week 24

Trial details

NCT IDNCT04795427

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-29

View on ClinicalTrials.gov More Leukemia, Chronic Myelogenous trials