Asciminib + Imatinib for Chronic Myeloid Leukemia

Recruiting at30 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib versus asciminib 80mg in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults over 18 with Chronic Myeloid Leukemia in chronic phase (CML-CP) who have been treated with imatinib for at least a year and haven't achieved deep molecular response. They must meet specific blood, liver, and kidney health criteria. Excluded are those with heart issues, history of pancreatitis or other cancers within the last 3 years, or previous treatment failures on imatinib.

Inclusion Criteria

I have been treated with imatinib for at least a year for my CML-CP.

Patient must meet specific laboratory values before randomization: Absolute Neutrophil Count ≥ 1.5 x 10E9/L, Platelets ≥ 75 x 10E9/L, Hemoglobin ≥ 9 g/dL, Serum creatinine < 1.5 mg/dL, Total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's syndrome), Aspartate transaminase (AST) ≤ 3.0 x ULN, Alanine transaminase (ALT) ≤ 3.0 x ULN, Alkaline phosphatase ≤ 2.5 x ULN, Serum lipase ≤ 1.5 x ULN. Patients must have other laboratory values within normal limits or corrected with supplements prior to randomization.

In Korea, I've been treated with imatinib for at least 1 or 2 years based on my BCR-ABL levels.

Exclusion Criteria

History or current diagnosis of ECG abnormalities indicating significant risk or safety for subjects participating in the study

I haven't had any other cancer besides this one in the last 3 years.

I have been treated with a tyrosine kinase inhibitor other than imatinib.

Treatment Details

Interventions

• Asciminib (Tyrosine Kinase Inhibitor)
• Imatinib (Tyrosine Kinase Inhibitor)
• Nilotinib (Tyrosine Kinase Inhibitor)

Trial Overview The study tests the effectiveness and safety of adding Asciminib to Imatinib versus continuing only Imatinib or switching to Nilotinib or using Asciminib alone in patients previously treated for CML-CP. It also examines how these drugs interact within the body.

Participant Groups

Group I: Asciminib 60mg QD + Imatinib 400mg QD Experimental Treatment 2 Interventions

Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily

Group II: Asciminib 40mg QD + Imatinib 400mg QD Experimental Treatment 2 Interventions

Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily

Group III: Imatinib 400mg QD Active Control 1 Intervention

Imatinib 400 mg taken once daily

Group IV: Nilotinib 300mg BID Active Control 1 Intervention

Nilotinib 300 mg taken twice daily

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD