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Asciminib for Chronic Myeloid Leukemia

Phase 2

Waitlist Available

Led By Ghayas C Issa

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

Patients must have received TKI therapy for at least 24 months and not have required dose reductions, escalations, discontinuation or re-initiation after discontinuation of TKI in the last 6 months

Patients with a diagnosis of Philadelphia chromosome (Ph)- or BCR-ABL1-positive CML (as determined by cytogenetics, fluorescence in situ hybridization [FISH], or polymerase chain reaction [PCR])

Must not have

Patients with a history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block)

Previous treatment with or known/ suspected hypersensitivity to ABL001 or any of its excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying ABL001 as a possible treatment for CML patients who are already on TKI therapy. ABL001 may work by blocking enzymes needed for cell growth. Giving ABL001 and TKI together may be more effective than TKI alone.

Who is the study for?

This trial is for chronic myeloid leukemia patients who've been on tyrosine kinase inhibitor therapy for at least 2 years without needing changes in the last 6 months. They must have certain levels of disease markers and normal organ function tests. Pregnant women, those with severe heart conditions or infections like HIV, and anyone with a history of pancreatitis or other active cancers are excluded.

What is being tested?

The study is testing ABL001's effectiveness when combined with tyrosine kinase inhibitors in treating chronic myeloid leukemia. It aims to see if this combination works better than the inhibitor alone by blocking enzymes that cancer cells need to grow.

What are the potential side effects?

While not explicitly listed, potential side effects may include issues related to enzyme inhibition such as fatigue, digestive problems, skin reactions, liver abnormalities, and an increased risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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I've been on TKI therapy for 2+ years without changes in the last 6 months.

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My leukemia is positive for the Philadelphia chromosome or BCR-ABL1.

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I am currently on nilotinib or dasatinib at a standard dose or lower.

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I can take care of myself and do some daily activities.

Exclusion Criteria

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

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I have had a heart attack or severe heart issues in the last 6 months.

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I am allergic or have had a bad reaction to ABL001 or its ingredients.

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I am not taking strong medication that affects liver enzymes or cannot stop it before starting the study treatment.

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I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.

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My heart's pumping ability is significantly reduced.

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I have an active HIV, hepatitis B, or hepatitis C infection.

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I have a condition that affects how my body absorbs pills.

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I have had acute pancreatitis in the last year or have chronic pancreatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Rate of molecular response

Secondary study objectives

Event free survival

Mismatch repair status

Overall survival

+1 more

Other study objectives

Incidence of adverse events

Interference score

MD Anderson Symptom Inventory (MDASI)-Chronic Myeloid Leukemia (CML) score

+1 more

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%

Pain in extremity

20%

Cough

20%

Dyspnoea

16%

Lipase increased

16%

Back pain

16%

Sinusitis

16%

Oropharyngeal pain

16%

Hypertension

12%

Pyrexia

12%

Vomiting

12%

Dry mouth

12%

Constipation

12%

Insomnia

12%

Non-cardiac chest pain

12%

Gastrooesophageal reflux disease

12%

Nausea

12%

Fall

12%

Aspartate aminotransferase increased

12%

Amylase increased

12%

Dizziness

Abdominal pain upper

Myalgia

Neutrophil count decreased

Anxiety

Platelet count decreased

Pruritus

Thrombocytopenia

Hypokalaemia

Oedema peripheral

Alanine aminotransferase increased

Upper respiratory tract infection

Pleural effusion

Rhinorrhoea

Memory impairment

Flank pain

Night sweats

Muscular weakness

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 (asciminib)Experimental Treatment1 Intervention

Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Asciminib

2018

Completed Phase 1

~570

0 / 12Eligibility criteria met