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Tyrosine Kinase Inhibitor
Asciminib for Chronic Myeloid Leukemia (ASC2ESCALATE Trial)
Verified Trial
Phase 2
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
You have chronic myeloid leukemia that is not is the blastic or accelerated phase
Be older than 18 years old
Must not have
History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
You have not had a stem-cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 12, 18, 24, 30 and 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trialwill test a new drug to treat chronic myeloid leukemia in those who haven't responded to other treatments.
Who is the study for?
This trial is for adults with chronic myeloid leukemia who have either failed or couldn't tolerate their first treatment, or are newly diagnosed and treated briefly. They should be in good physical condition, not in the advanced stages of leukemia, and without serious heart issues or a history of certain other cancers.
What is being tested?
Asciminib (Scemblix) is being tested as a solo treatment for chronic myeloid leukemia. The study will include patients previously treated with one TKI drug that didn't work well or caused side effects, as well as new patients who've had minimal prior treatment.
What are the potential side effects?
While specific side effects aren't listed here, asciminib may cause changes in blood counts, liver enzymes, pancreatitis risk increase; it could also affect heart rhythm potentially leading to severe cardiac events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My chronic myeloid leukemia is in the early or chronic phase.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had any cancer except for basal cell skin cancer or treated carcinoma in situ in the last 3 years.
Select...
I have not undergone a stem-cell transplant.
Select...
I have never taken the medication Scemblix.
Select...
My heart has no abnormalities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3, 6, 12, 18, 24, 30 and 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, 12, 18, 24, 30 and 36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of participants who achieve Major Molecular Response (MMR) in the 2L setting
Secondary study objectives
Duration of MMR
MMR Rate at visit (other than 12 month)
MMR Rate by visit
+12 moreOther study objectives
To investigate MR2, MR4, MR4.5 rate at visit
Side effects data
From 2024 Phase 3 trial • 56 Patients • NCT0466625936%
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
8%
Abdominal pain upper
8%
Myalgia
8%
Neutrophil count decreased
8%
Anxiety
8%
Platelet count decreased
8%
Pruritus
8%
Thrombocytopenia
8%
Hypokalaemia
8%
Oedema peripheral
8%
Alanine aminotransferase increased
8%
Upper respiratory tract infection
8%
Pleural effusion
8%
Rhinorrhoea
4%
Muscular weakness
4%
Memory impairment
4%
Flank pain
4%
Night sweats
4%
Alopecia
4%
COVID-19 pneumonia
4%
Neuroendocrine tumour
4%
Palpitations
4%
Pelvic infection
4%
Meniscus injury
4%
Brain stem infarction
4%
Chronic obstructive pulmonary disease
4%
Urinary tract infection
4%
Nasal congestion
4%
Hot flush
100%
80%
60%
40%
20%
0%
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: AsciminibExperimental Treatment1 Intervention
80 mg initial oral dose taken once a day with possible dose escalation
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,921 Previous Clinical Trials
4,254,116 Total Patients Enrolled
NovartisStudy DirectorNovartis
283 Previous Clinical Trials
68,996 Total Patients Enrolled
Rodrigo Maegawa, MDStudy DirectorNovartis
Daisy Yang, PhDStudy DirectorNovartis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received previous treatment.I do not have Long QT syndrome or a family history of sudden death.I am not taking any strong drugs that affect liver enzymes with my 200 mg twice daily medication.I haven't had any cancer except for basal cell skin cancer or treated carcinoma in situ in the last 3 years.I experienced severe side effects from my cancer treatment that didn't improve with changes.I've had severe blood-related side effects from treatment, even after the dose was lowered.I have risk factors for a specific heart rhythm problem due to low potassium or magnesium, heart failure, or slow heartbeat.My BCR-ABL1 levels are above 10% after 6-12 months of first-line treatment.I have been treated with 2 or more TKIs.My first treatment with a TKI drug did not work.I have had a stem-cell transplant before.I can take care of myself and am up and about more than half of my waking hours.I am not taking medication that strongly activates CYP3A enzymes.My heart has no abnormalities.My BCR-ABL1 levels are above 0.1%.It's been over a year since I started my first-line TKI treatment.I have newly diagnosed chronic myeloid leukemia and may have had up to 4 weeks of treatment with specific drugs.You are allergic to the study treatment.I am planning to have a stem cell transplant from a donor.My chronic myeloid leukemia is in the early or chronic phase.I have never taken the medication Scemblix.I'm sorry, but it seems like there is no specific criterion provided. Could you please provide more information or context?I have not undergone a stem-cell transplant.I have had acute pancreatitis in the last year or have chronic pancreatitis.I have not taken ATP-binding site TKIs for my condition in the last 4 weeks.I am 18 years old or older.Intolerance means that you have a negative reaction or cannot tolerate something.My cancer has the T315I mutation.I have been treated with asciminib before.My first treatment for leukemia did not work as expected.My leukemia has worsened despite treatment for over a year.My organs are functioning well enough for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Asciminib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.