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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 96 weeks after the last patient received the first study dose

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My last treatment with a TKI did not work or caused side effects.

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I am 18 or older with chronic myeloid leukemia in the chronic phase.

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My BCR-ABL1 ratio is above 0.1%, and I can't tolerate my current TKI therapy.

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I have been treated with at least 2 types of targeted cancer drugs before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 weeks after the last patient received the first study dose

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Major Molecular Response (MMR) Rate at 24 Weeks

Secondary outcome measures

Complete Cytogenetic Response Rate

Duration of CCyR

Duration of MMR

+11 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,120 Total Patients Enrolled

151 Trials studying Leukemia

23,599 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you please explain the risks and side effects associated with ABL001?

"ABL001 is a phase 3 trial medication, which means that it has passed multiple safety tests and has some efficacy data. Therefore, it received a score of 3."

Answered by AI

Are there other examples of ABL001 being tested in a medical setting?

"ABL001 was first researched in 2014 by Novartis at an investigative site. Since then, there have been a total of 39 clinical trials completed with 24 active studies. Many of these trials are based out of Beech Grove, Indiana."

Answered by AI

For what medical conditions is ABL001 commonly prescribed?

"ABL001 has shown to be an effective treatment against refractory, accelerated phase chronic myelogenous leukemia, refractory, blast phase chronic myelogenous leukemia, and myeloid leukemia, chronic, chronic phase."

Answered by AI

Does this research stand alone or has it been done before?

"ABL001 has been through 24 clinical trials in the 6 years since it was first studied in 2014. These trials have taken place in 481 cities across 45 countries. The first trial, sponsored by Novartis Pharmaceuticals, involved 326 patients and completed Phase 1 approval. In the intervening years, 39 more studies have been completed."

Answered by AI

Are there a limited number of places where this research is conducted?

"At the moment, 11 sites are running this study. The trial locations include the Indiana Blood and Marrow Institute Regulatory - 2 in Beech Grove, Sidney Kimmel Comprehensive Cancer Center in Baltimore, and Weill Cornell Medicine NewYork Presbyterian Hospital in New york."

Answered by AI

Recent research and studies

BloodJournal

A Phase 3, Open-label, Randomized Study of Asciminib, a STAMP Inhibitor, Vs Bosutinib in CML After 2 or More Prior Tkis

Réa, Delphine, Michael J. Mauro, Carla Boquimpani, Yosuke Minami, Elza Lomaia, Sergey Voloshin, Anna Turkina, et al.. 2021. “A Phase 3, Open-label, Randomized Study of Asciminib, a STAMP Inhibitor, Vs Bosutinib in CML After 2 or More Prior Tkis”. Blood. American Society of Hematology. doi:10.1182/blood.2020009984.

BloodJournal

A Phase 3, Open-label, Randomized Study of Asciminib, a STAMP Inhibitor, Vs Bosutinib in CML After 2 or More Prior Tkis

Clinical PharmacokineticsJournal

Population Pharmacokinetics of Asciminib in Tyrosine Kinase Inhibitor-treated Patients with Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic and Acute Phases

Li, Ying Fei, Francois Pierre Combes, Matthias Hoch, Sebastien Lorenzo, Sherwin K. B. Sy, and Yu-Yun Ho. 2022. “Population Pharmacokinetics of Asciminib in Tyrosine Kinase Inhibitor-treated Patients with Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic and Acute Phases”. Clinical Pharmacokinetics. Springer Science and Business Media LLC. doi:10.1007/s40262-022-01148-9.

Clinical PharmacokineticsJournal

Population Pharmacokinetics of Asciminib in Tyrosine Kinase Inhibitor-treated Patients with Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic and Acute Phases