What side effects are associated with this type of intervention?

Common treatments for Chronic Myeloid Leukemia (CML) include tyrosine kinase inhibitors (TKIs) such as imatinib, nilotinib, dasatinib, and bosutinib. These treatments can have various side effects. Imatinib is often associated with edema, nausea, muscle cramps, and rash. Nilotinib can cause elevated blood sugar levels, liver enzyme abnormalities, and cardiovascular issues. Dasatinib may lead to pleural effusion, bleeding complications, and pulmonary arterial hypertension. Bosutinib's side effects include diarrhea, liver enzyme elevations, and abdominal pain. Asciminib, a newer TKI, is noted for potentially having a lower cardiotoxicity profile compared to some other TKIs.

What prior FDA approvals exist?

The FDA has approved several tyrosine kinase inhibitors (TKIs) for the treatment of Chronic Myeloid Leukemia (CML). These include imatinib, the first TKI approved, which targets the BCR-ABL fusion protein. Following imatinib, second-generation TKIs such as dasatinib, nilotinib, and bosutinib were approved, offering options for patients with resistance or intolerance to imatinib. Ponatinib, a third-generation TKI, is effective against the T315I mutation, a common resistance mutation. Asciminib, an allosteric inhibitor of ABL1 kinase, represents a novel approach by targeting the myristoyl pocket of ABL1, potentially overcoming resistance seen with other TKIs.

What other types of research exist?

Promising, novel alternatives to Asciminib for Chronic Myeloid Leukemia patients include other TKIs such as imatinib, nilotinib, dasatinib, and bosutinib. Additionally, ongoing research and clinical trials may introduce new TKIs or combination therapies that could be available in 2024. Patients should discuss with their healthcare provider to determine the most appropriate treatment based on the latest available options and their individual health profile.

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Tyrosine Kinase Inhibitor

Asciminib vs Other TKIs for Chronic Myeloid Leukemia

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of Philadelphia chromosome

Adequate end organ function as defined by specific criteria for total bilirubin, creatinine clearance, and serum lipase

Must not have

Impaired cardiac function or cardiac repolarization abnormality including specific conditions and QTc intervals

History of significant congenital or acquired bleeding disorder unrelated to cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up planned total follow-up duration of 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include nausea, muscle pain, headaches, fatigue, digestive problems like diarrhea or constipation, skin rash and increased risk of infections. Heart rhythm problems could also occur but are monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My liver, kidneys, and pancreas are functioning well.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have a history of pancreatitis.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ planned total follow-up duration of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~planned total follow-up duration of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and planned total follow-up duration of 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major Molecular Response (MMR) at week 48

Secondary study objectives

BCR-ABL1≤1% at scheduled data collection time points

BCR-ABL1≤1% by scheduled data collection time points

Change from baseline in overall scores and individual scales of the EORTC QLQ-C30

+29 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Asciminib

2018

Completed Phase 1

~570

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Myeloid Leukemia (CML) are tyrosine kinase inhibitors (TKIs) such as imatinib, dasatinib, nilotinib, and bosutinib. These drugs target the BCR-ABL fusion protein, a constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality, which drives the uncontrolled proliferation of leukemic cells. By inhibiting the BCR-ABL kinase activity, TKIs effectively reduce leukemic cell growth and induce remission. Asciminib, an allosteric inhibitor of ABL1 kinase, represents a novel approach by binding to a different site on the BCR-ABL protein, potentially overcoming resistance seen with other TKIs. Understanding these mechanisms is crucial for CML patients as it directly impacts treatment efficacy, resistance management, and long-term outcomes.

Targeted chronic myeloid leukemia therapy: seeking a cure.