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Tyrosine Kinase Inhibitor

Asciminib for Chronic Myelogenous Leukemia

Phase 2

Recruiting

Led By Elias Jabbour, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured

ECOG performance status ≤2

Must not have

Pregnant women are excluded from this study because asciminib is a BCR::ABL1 TKI with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with asciminib, breastfeeding should be discontinued if the mother is treated with asciminib. These potential risks may also apply to other agents used in this study

Participants in late chronic phase (i.e., time from diagnosis to treatment >12 months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate if asciminib can effectively manage chronic myeloid leukemia (CML). The study will also assess the safety and potential benefits of this medication.

Who is the study for?

Adults over 18 with newly diagnosed Chronic Myeloid Leukemia in early phase (diagnosed within the last year) who have good organ function and no severe concurrent conditions. Must not be pregnant or breastfeeding, agree to use contraception, and can't have had extensive prior cancer treatments or certain heart diseases.

What is being tested?

The trial is testing Asciminib's effectiveness and safety for controlling Chronic Myeloid Leukemia in its early stage. It will compare how well patients respond to this drug versus their condition without it.

What are the potential side effects?

Asciminib may cause side effects such as liver issues, digestive disturbances, potential bleeding disorders, fatigue, muscle aches, and could potentially affect heart rhythm.

Eligibility Criteria

Inclusion Criteria

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

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I had hepatitis C but have been successfully treated and cured.

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I can take care of myself but might not be able to do heavy physical work.

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My liver and kidney functions are within the required limits.

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I have chronic hepatitis B but it's under control with treatment.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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My cancer is not in the late chronic, accelerated, or blast phase.

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I have taken FDA-approved TKI for over 30 days or had more than 2 doses of cytarabine.

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I have or might have long QT syndrome.

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I do not have any uncontrolled infections.

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I have never had serious irregular heartbeats.

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My cancer has the T315I mutation.

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I have severe heart disease.

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I have not had unstable chest pain in the last 3 months.

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I am being treated for chronic hepatitis B or C with a detectable virus load.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and adverse events (AEs)

Side effects data

From 2024 Phase 3 trial • 56 Patients • NCT04666259

36%

Fatigue

36%

Headache

28%

COVID-19

24%

Rash

24%

Diarrhoea

24%

Arthralgia

24%

Abdominal pain

20%

Cough

20%

Pain in extremity

20%

Dyspnoea

16%

Lipase increased

16%

Back pain

16%

Sinusitis

16%

Oropharyngeal pain

16%

Hypertension

12%

Pyrexia

12%

Vomiting

12%

Dry mouth

12%

Insomnia

12%

Constipation

12%

Non-cardiac chest pain

12%

Gastrooesophageal reflux disease

12%

Nausea

12%

Fall

12%

Aspartate aminotransferase increased

12%

Amylase increased

12%

Dizziness

Myalgia

Abdominal pain upper

Neutrophil count decreased

Anxiety

Platelet count decreased

Pruritus

Thrombocytopenia

Hypokalaemia

Oedema peripheral

Alanine aminotransferase increased

Upper respiratory tract infection

Pleural effusion

Rhinorrhoea

Muscular weakness

Memory impairment

Flank pain

Night sweats

Alopecia

COVID-19 pneumonia

Neuroendocrine tumour

Palpitations

Pelvic infection

Meniscus injury

Brain stem infarction

Chronic obstructive pulmonary disease

Urinary tract infection

Nasal congestion

Hot flush

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort C

Cohort B

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with AsciminibExperimental Treatment1 Intervention

Participants will take tablets of asciminib by mouth every day on this study. Participants should take it at least 1 hour before and 2 hours after eating. The tablets should be swallowed whole, not crushed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Asciminib

2018

Completed Phase 1

~570

0 / 14Eligibility criteria met