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Tyrosine Kinase Inhibitor
Asciminib for Chronic Myeloid Leukemia
Phase 2
Waitlist Available
Led By Ghayas Issa, 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
History of treatment failure defined as either: BCR::ABL1 >0.1% for patients with intolerance to first-line TKI, Less than complete hematologic response (CHR) at ≥3 months, No partial cytogenetic response at ≥3 months, BCR::ABL1 ≥ 10% at 3-6 months, BCR::ABL1 ≥ 1% at ≥6 months, Loss of CCyR or development of mutations or other clonal chromosomal abnormalities at any time during TKI treatment
ECOG performance status ≤ 2
Must not have
Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF < 40% by echocardiogram or multi-gated acquisition (MUGA) scan
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 AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months of therapy
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how well and how safe avapritinib is for patients with certain types of cancer that have specific genetic mutations.
Who is the study for?
This trial is for individuals with Chronic Myeloid Leukemia in the chronic phase who have already tried at least one treatment. Participants should have a specific mutation in their cancer cells (CKIT or PDGFRA).
What is being tested?
The study is testing Asciminib's effectiveness and safety as a second-line treatment for Chronic Myeloid Leukemia. It aims to see how well patients respond to this medication after other treatments.
What are the potential side effects?
Possible side effects of Asciminib may include nausea, fatigue, muscle pain, and changes in blood counts which could lead to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My previous treatment for leukemia did not work as expected.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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I have chronic phase CML with a positive Ph or BCR-ABL and have had one prior TKI treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe heart failure or a heart pumping efficiency below 40%.
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I have had a heart attack in the last 6 months or have serious heart rhythm problems.
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I am not pregnant, nursing, or if capable of becoming pregnant, I agree to use effective contraception.
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I don't have Long QT syndrome, a family history of sudden death, or risk factors for Torsades de Pointes.
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I have a history of the T315I mutation.
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I have had acute pancreatitis in the last year or have chronic pancreatitis.
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I do not have an active HIV, Hepatitis B, or C infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months of therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months of therapy
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) rate by 12 months
Side effects data
From 2024 Phase 3 trial • 56 Patients • NCT0466625967%
Nausea
33%
Anaemia
33%
Vomiting
33%
Fatigue
33%
Oedema peripheral
33%
Arthralgia
33%
Hyperglycaemia
33%
Memory impairment
33%
Insomnia
33%
Thrombocytopenia
33%
Malaise
33%
Abdominal distension
33%
Viral diarrhoea
33%
Alanine aminotransferase increased
33%
Pain in extremity
33%
Rash
33%
Hot flush
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort C
Cohort A
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: AsciminibExperimental Treatment1 Intervention
Patients will receive asciminib 80 mg once daily continuously for 28-day cycles for 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Asciminib
2018
Completed Phase 1
~570
Find a Location
Who is running the clinical trial?
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,263 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,505 Total Patients Enrolled
Ghayas Issa, MDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center
3 Previous Clinical Trials
66 Total Patients Enrolled