Asciminib + Imatinib for Chronic Myeloid Leukemia

Recruiting at 30 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Imatinib

Must not be taking: Other TKIs

Disqualifiers: Uncontrolled diabetes, Pancreatitis, ECG abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 96 weeks

104 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive randomized treatment with asciminib in combination with imatinib, continued imatinib, or switch to nilotinib for up to 96 weeks

96 weeks

Cross-over

Participants on the imatinib continuation arm who have not achieved MR4.5 at 48 weeks may cross-over to receive asciminib 60 mg combination add-on treatment

4 weeks after week 48

Follow-up

Participants are monitored for safety for 30 days after the last dose received

4 weeks

Treatment Details

Interventions

• Asciminib
• Imatinib
• Nilotinib

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

Asciminib is already approved in United States, European Union for the following indications:

Approved in United States as Scemblix for:

• Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) in adults previously treated with ≥2 tyrosine kinase inhibitors (TKIs)
• Ph+ CML in CP with the T315I mutation
• newly diagnosed Ph+ CML in CP

Approved in European Union as Scemblix for:

• Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) in adults previously treated with ≥2 tyrosine kinase inhibitors (TKIs)
• Ph+ CML in CP with the T315I mutation

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