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BCR-ABL Tyrosine Kinase Inhibitor

Asciminib + Imatinib for Chronic Myeloid Leukemia

Phase 3

Recruiting

Led By Sarit E Assouline, MD, MSc

Research Sponsored by Sarit Assouline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0-2

Male or female patients aged at least 18 years with a confirmed diagnosis of CML-CP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tki discontinuation until loss of mr3 (up to 1 year)

Awards & highlights

Study Summary

This trial aims to see if adding a new drug to an existing one can improve cancer treatment in Leukemia patients.

Who is the study for?

Adults diagnosed with Chronic Phase-Chronic Myelogenous Leukemia (CML-CP) who have been treated with imatinib for over 4 years and are in deep molecular response for at least a year. They must be able to conceive and agree to use effective contraception, have good organ function, no history of certain severe diseases or conditions that could affect trial participation, and not be on conflicting medications.Check my eligibility

What is being tested?

The study is testing if adding asciminib to the current imatinib treatment leads to better rates of Treatment-Free Remission (TFR) compared to using imatinib alone in patients with CML-CP who are already responding well to treatment.See study design

What are the potential side effects?

Potential side effects include digestive issues, liver enzyme changes, blood cell count variations, muscle cramps, bone pain, fatigue, rash or other skin problems. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I am able to get out of my bed or chair and move around.

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

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I have been taking a 400 mg or 300 mg oral medication daily for at least 6 months.

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My chronic myeloid leukemia has been in deep remission for at least a year.

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I have been on Imatinib for more than 4 years.

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I have not had advanced chronic myeloid leukemia or resistance to specific leukemia treatment.

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I am not pregnant and will use effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tki discontinuation until loss of mr3 (up to 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tki discontinuation until loss of mr3 (up to 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and tki discontinuation until loss of mr3 (up to 1 year) for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

Association between duration of deep molecular response (DMR) and TFR (Treatment Free Remission) as assessed by Hazard Ratio

Association between duration of prior imatinib exposure and TFR (Treatment Free Remission) as assessed by Hazard Ratio

Cumulative incidence of adverse events grade ≥ 3 in each arm, using CTCAE 5.0

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Imatinib and AsciminibExperimental Treatment2 Interventions

Asciminib (60 mg PO daily for 52 weeks) will be added to standard of care imatinib (300 or 400 mg PO daily for 52 weeks)

Group II: ImatinibActive Control1 Intervention

Standard of care imatinib at 300 or 400 mg PO daily for 52 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Asciminib

2018

Completed Phase 1

~570

Imatinib

2011

Completed Phase 3

~3940

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sarit AssoulineLead Sponsor

2 Previous Clinical Trials

65 Total Patients Enrolled

1 Trials studying Leukemia

23 Patients Enrolled for Leukemia

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,720,871 Total Patients Enrolled

55 Trials studying Leukemia

10,176 Patients Enrolled for Leukemia

Sarit E Assouline, MD, MScPrincipal InvestigatorSMBD Jewish General Hospital CIUSSS West Central Montreal

Media Library

Imatinib (BCR-ABL Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05413915 — Phase 3

Leukemia Research Study Groups: Imatinib and Asciminib, Imatinib

Leukemia Clinical Trial 2023: Imatinib Highlights & Side Effects. Trial Name: NCT05413915 — Phase 3

Imatinib (BCR-ABL Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05413915 — Phase 3

Frequently Asked Questions

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

Are there any additional participants being accepted for this clinical experiment?

"According to clinicaltrials.gov, this research is still seeking volunteers. The posting for the trial was first published on June 19th 2023 and last revised on June 20th of that same year."

Answered by AI

What is the current quota for enrolment in this experiment?

"Affirmative, the clinical trial is currently recruiting for 164 individuals across a single site. The study was posted on June 19th 2023 and updated most recently on June 20th of that same year."

Answered by AI

Have Imatinib and Asciminib been given the go-ahead by the FDA?

"The safety of Imatinib and Asciminib have been assessed to be a 3 based on their Phase 3 status, implying that there is both proof of efficacy as well as additional data validating the treatments' safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML

Sarit Assouline 2023. "Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05413915.

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