Asciminib vs Other TKIs for Chronic Myeloid Leukemia

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called asciminib against other existing treatments for adults newly diagnosed with a specific type of leukemia. The goal is to see if asciminib is more effective at blocking a protein that helps cancer cells grow. Asciminib has shown superior efficacy in patients with chronic myeloid leukemia (CML) previously treated with multiple other treatments.

Eligibility Criteria

Adults over 18 with newly diagnosed Ph+ CML-CP within the last 3 months, who haven't been treated for it yet. They must have normal or correctable levels of certain blood elements and organ functions, no severe heart issues or other serious medical conditions, and an ECOG performance status of 0 or 1.

Inclusion Criteria

My leukemia is in the chronic phase and has been confirmed to have the Philadelphia chromosome.

My liver, kidneys, and pancreas are functioning well.

My chronic myeloid leukemia is in the chronic phase without severe symptoms.

I am fully active or restricted in physically strenuous activity but can do light work.

My leukemia has a specific genetic marker that can be measured.

Exclusion Criteria

My heart function is not normal, or I have an abnormal heart rhythm.

I have a history of serious bleeding problems not related to cancer.

I have a long-term liver condition causing severe liver damage.

I have a history of pancreatitis.

I haven't had major surgery in the last 4 weeks or am still recovering from one.

Treatment Details

The trial is testing Asciminib (80 mg daily) against other TKIs chosen by the investigator: Imatinib (400 mg daily), Nilotinib (300 mg twice a day), Dasatinib (100 mg daily), or Bosutinib (400 mg daily). It aims to find out which treatment works best for new CML-CP patients.

2Treatment groups

Experimental Treatment

Active Control

Group I: AsciminibExperimental Treatment1 Intervention

Patients will take asciminib 80 mg QD under fasting conditions on ongoing basis; Patients will be randomized 1:1 asciminib versus Investigator selected TKIs

Group II: Investigator selected TKIsActive Control4 Interventions

Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments: Imatinib 400 mg QD administered with food Nilotinib 300 mg BID administered under fasting conditions Dasatinib 100 mg QD administered with or without a meal Bosotunib 400 mg QD administered with food

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