TerminatedPhase 3

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

Stopped: Insufficient patient accrual

Canada8 participantsStarted 2023-11-01

Plain-language summary

The aim of this study is to establish if consolidation of imatinib-treated patients in stable DMR through the addition of asciminib, can lead to superior rates of TFR1, compared to imatinib alone in Chronic Phase-Chronic Myelogenous Leukemia patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female patients aged at least 18 years of age with a confirmed diagnosis of CML-CP.
. Written informed consent prior to any screening procedures
. Available and willing to comply with all study assessments.
. Imatinib treatment ongoing \> 4 years, and currently receiving:
. CML in deep molecular response (DMR, at least MR4 IS) for at least 12 months prior to randomization (documented through at least 3 PCRs test results over the period of 12 months prior to randomization, showing BCR-ABL1 levels ≤ 0.01% IS (International Scale) and no result over \>0.01%). For patients receiving 300 mg imatinib QD, minimum of two (2) of those qPCRs evaluations must have been obtained at least 3 months apart while on 300 mg imatinib.
. ECOG performance status of 0-2.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Event-free survival rate

Timeframe: randomization until 12 months after discontinuation of all TKI among randomized patients

Trial details

NCT IDNCT05413915

SponsorSarit Assouline

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-02

View on ClinicalTrials.gov More Chronic Myeloid Leukemia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female patients aged at least 18 years of age with a confirmed diagnosis of CML-CP.
. Written informed consent prior to any screening procedures
. Available and willing to comply with all study assessments.
. Imatinib treatment ongoing \> 4 years, and currently receiving:
. CML in deep molecular response (DMR, at least MR4 IS) for at least 12 months prior to randomization (documented through at least 3 PCRs test results over the period of 12 months prior to randomization, showing BCR-ABL1 levels ≤ 0.01% IS (International Scale) and no result over \>0.01%). For patients receiving 300 mg imatinib QD, minimum of two (2) of those qPCRs evaluations must have been obtained at least 3 months apart while on 300 mg imatinib.
. ECOG performance status of 0-2.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria