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Tyrosine Kinase Inhibitor

Asciminib vs Bosutinib for Chronic Myelogenous 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
Failure or intolerance to the most recent TKI therapy at the time of screening
Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
Must not have
Previous treatment with a hematopoietic stem-cell transplantation
Treatment with medications that are moderate or strong inducers or inhibitors of CYP3A
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks after the last patient received the first study dose
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial compared the efficacy of two different drugs in treating patients with CML-CP who had previously been treated with a minimum of two other drugs.

Who is the study for?
This trial is for adults with chronic myelogenous leukemia in the chronic phase (CML-CP) who have already tried at least two prior ATP-binding site TKIs and either didn't respond well or couldn't tolerate them. They must not have certain mutations, a history of heart issues, or severe concurrent diseases. Women of childbearing potential must use effective contraception.
What is being tested?
The study compares asciminib (ABL001) to bosutinib in patients with CML-CP who've had inadequate responses to previous treatments. It aims to determine which drug is more effective after failure or intolerance to at least two other therapies.
What are the potential side effects?
Potential side effects include blood disorders like low platelet counts, digestive issues such as pancreatitis, liver problems, and cardiac complications including abnormal heart rhythms. Specific side effects will vary between asciminib and bosutinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My last treatment with a TKI did not work or caused side effects.
Select...
I am 18 or older with chronic myeloid leukemia in the chronic phase.
Select...
My BCR-ABL1 ratio is above 0.1%, and I can't tolerate my current TKI therapy.
Select...
I have been treated with at least 2 types of targeted cancer drugs before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a stem-cell transplant before.
Select...
I am not taking drugs that strongly affect liver enzyme CYP3A.
Select...
I have risk factors for a rare heart rhythm problem.
Select...
I have a history of liver disease.
Select...
I am not using highly effective birth control methods.
Select...
My CML has returned to a chronic phase after worsening.
Select...
I have or my family has a history of sudden death or Long QT syndrome.
Select...
I have had acute pancreatitis in the last year or have chronic pancreatitis.
Select...
My cancer has the T315I or V299L mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks after the last patient received the first study dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks after the last patient received the first study dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Major Molecular Response (MMR) Rate at 24 Weeks
Secondary study objectives
Complete Cytogenetic Response Rate
Duration of CCyR
Duration of MMR
+11 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 were randomized to asciminib 40mg BID
Group II: BosutinibActive Control1 Intervention
Patients were randomized to bosutinib 500mg QD
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?

Novartis PharmaceuticalsLead Sponsor
2,921 Previous Clinical Trials
4,254,079 Total Patients Enrolled
161 Trials studying Leukemia
26,209 Patients Enrolled for Leukemia

Media Library

ABL001 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03106779 — Phase 3
Leukemia Research Study Groups: Bosutinib, Asciminib
Leukemia Clinical Trial 2023: ABL001 Highlights & Side Effects. Trial Name: NCT03106779 — Phase 3
ABL001 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03106779 — Phase 3
~29 spots leftby Jan 2026
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