Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Official Title

A Phase 2, Multi-centre, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response

Summary:

To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)

Trial Description

Primary Outcome:

• Molecular Response (MR)^4.5 rate between asciminib+imatinib and imatinib alone

• MR^4.5 rate at 48 weeks
• Rate of MR^4.5 at 96 weeks
• Rate of MR^4.5 by 48 and 96 weeks
• Sustained MR^4.5 from 48 weeks until 96 weeks
• Time to MR^4.5
• Difference in rate of MR^4.5 at 48 weeks
• Pharmacokinetic profile of asciminib and imatinib when administered in combination - Cmax
• Pharmacokinetic profile of asciminib and imatinib when administered in combination - Tmax
• Pharmacokinetic profile of asciminib and imatinib when administered in combination - Cmin
• Pharmacokinetic profile of asciminib and imatinib when administered in combination - AUClast
• Pharmacokinetic profile of asciminib and imatinib when administered in combination - AUCtau

View this trial on ClinicalTrials.gov