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
Secondary Outcome:
  • 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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society