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Chronic Myeloid LeukemiaPhase 3NCT05413915

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

A Phase 3 study testing Asciminib and Imatinib in people with Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, BCR/ABL-Positive, run by Sarit Assouline at 4 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Asciminib and Imatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
4 sitesCanada
Study dates
1 Nov 2023to 2 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In order to be eligible, candidates must fulfill all the following 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:
  • Standard dose 400 mg PO QD or;
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  • 300 mg PO QD for at least 6 months (see below)
  • 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.
  • Adequate organ function, defined by:
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L
  • Platelets ≥ 75 x 10^9/L (without the requirement for transfusion for 14 days)
  • Hemoglobin ≥ 90 g/L (without the requirement for transfusion for 14 days)
  • Serum creatinine < 132 µmol/L
  • Total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's syndrome who may only be included with total bilirubin ≤ 3.0 x ULN)
  • Aspartate transaminase (AST) ≤ 3.0 x ULN
  • Alanine transaminase (ALT) ≤ 3.0 x ULN
  • Alkaline phosphatase ≤ 2.5 x ULN
  • Serum lipase ≤ 1.5 x ULN
  • Serum levels of potassium, magnesium, total calcium within the normal laboratory range. Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed.
  • potassium increase of up to 6.0 mmol/L is acceptable if associated with creatinine clearance within normal limits (as estimated by the Cockcroft-Gault formula, appendix 1)
  • calcium increase to 3.1 mmol/L is acceptable if associated with creatinine clearance within normal limits
  • magnesium increase up to 1.23 mmol/L if associated with creatinine clearance within normal limits
  • No previous CML-AP/BP by MDACC criteria nor resistance to TKI by ELN criteria.
  • Never attempted TFR
  • Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test before initiation of study treatment, and must also use highly effective methods of contraception to continue for at least 14 days after the last dose of study treatment, or for the duration of a monthly cycle of oral contraception, whichever is longer. Acceptable forms of highly effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • Male/female sterilization defined as: 1. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed and documented by follow up hormone level assessment 2. Male sterilization of the sole partner (at least 6 months prior to screening) of a female patient on the study.
  • A combination of any two of the following (i+ii or i+iii or ii+iii): i) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository ii) Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception iii) Placement of an intrauterine device (IUD) or intrauterine system (IUS)

Who cannot join

  • Patients known to be in second CP-CML after previous progression to AP/BC-CML
  • Previous treatment with a TKI other than imatinib.
  • Prior allogeneic transplant.
  • Tolerance concerns to continue imatinib on study, as determined by the investigator.
  • Treatment with strong inducers/inhibitors of CYP3A4.
  • Known atypical ABL1-BCR transcript that precludes use of IS system for monitoring.
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  • Current or prior history of another malignancy within the past 2 years, unless it is a solid tumor with a life expectancy of at least 3 years and its treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (for example, patients who have undergone complete resection of an in situ carcinoma, or who have a low risk indolent prostate cancer are eligible). History or current diagnosis of cardiac disease indicating significant risk or safety for subjects participating in the study such as:
  • History of myocardial infarction, angina pectoris, coronary artery bypass graft within 6 months prior to randomization
  • Concomitant clinically significant arrhythmias
  • Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) prior to randomization
  • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
  • Risk factors for Torsades de Pointes ii. Concomitant medications with a "known" risk of Torsades de Pointes iii. inability to accurately determine the QTcF interval, unless this is due to the presence of a pacemaker.
  • History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis; on-going acute liver disease or history of chronic liver disease
  • Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Subjects with other severe or uncontrolled medical conditions that in the opinion of the investigator may compromise their compliance with the protocol or may represent an unacceptable risk to their safety (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant hyperlipidemia and high serum amylase).
  • Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks of Day 1.
  • Known allergy or hypersensitivity to asciminib or any of its excipients.
  • Patients who are pregnant or breastfeeding or WOCBP not employing an effective method of birth control.
  • Known infection with Human Immunodeficiency virus (HIV), chronic Hepatitis B (HBV) or chronic hepatitis C infection (HCV). Hepatitis B and C testing will be performed at screening.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Hôpital Maisonneuve-Rosemont (CIUSSS EMTL)

    Montreal, Quebec, H1T 2M4

  • Clinical Research Unit - Jewish General Hospital

    Montreal, Quebec, H3T1E2

  • Hôpital Enfant-Jésus - CHUQ

    Québec, Quebec, G1J 1Z4

  • Hôpital Fleurimont - CHUS (CIUSSS Estrie)

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-Label, Trial Evaluating the Efficacy and Safety of Asciminib Used in Consolidation With Imatinib v. Imatinib to Achieve Treatment-free Remission in Chronic Phase-Chronic Myelogenous Leukemia Patients

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.

Being tested
Asciminib, Imatinib
Keywords
DMR
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AsciminibDrug

    Also called ABL-001

    Tyrosine kinase inhibitor

  • ImatinibDrug

    Also called Imatinib mesylate

    Tyrosine kinase inhibitor

Study groups in NCT05413915
Study groupRoleWhat they receive
ImatinibActive comparatorStandard of care imatinib at 300 or 400 mg PO daily for 52 weeks
Receives: Drug: Imatinib
Imatinib and AsciminibExperimentalAsciminib (60 mg PO daily for 52 weeks) will be added to standard of care imatinib (300 or 400 mg PO daily for 52 weeks)
Receives: Drug: Asciminib; Drug: Imatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival rate

    Occurrence of death or loss of deep molecular response (DMR, MR4 (4-log reduction in BCR-ABL1 or better)) or loss of major molecular response (MMR, MR3 (3-log reduction in BCR-ABL1)) at any time.

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

Secondary outcomes (6)

  1. Event-free survival rate

    Occurrence of death or "molecular relapse" as defined as any loss of MR4 status during the Consolidation period OR any loss of MR3 by qPCR at any time

    Measured: randomization to 6 months after discontinuation of TKI among all randomized patients

  2. Time to molecular relapse

    Time in months to loss of MR3 among subjects who attempt treatment-free remission (TFR)

    Measured: Tyrosine kinase inhibitor (TKI) discontinuation until loss of MR3 (up to 1 year)

  3. Molecular relapse free rate

    Sustained MR3 status at 12 months among patients who attempt TFR

    Measured: TKI discontinuation until loss of MR3 (up to 1 year)

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

    Safety and tolerability of asciminib when used with imatinib

    Measured: from first dose/randomization until 30 days post last dose

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

    Measured: from randomization until up to 12 months post consolidation

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

    Measured: from randomization until up to 12 months post consolidation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start1 Nov 2023
  3. Primary completion2 Jul 2025
  4. Study completion2 Jul 2025

Why it stopped: Insufficient patient accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 study phases: * Consolidation phase: 52 weeks of consolidation treatment on study with asciminib 60 mg PO QD in addition to current dose mg imatinib (300 or 400 mg PO QD) vs. current dose imatinib alone. * TFR follow up phase: all participants attempting TFR to be followed for CML remission status.
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413915
Sponsor's protocol ID
QC-TFR1-ABL001
Status last verified
May 2026
First submitted
31 May 2022
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Asciminib and Imatinib in people with Chronic Myeloid Leukemia and Chronic Myeloid Leukemia, BCR/ABL-Positive, run by Sarit Assouline at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Insufficient patient accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival rate (time frame: randomization until 12 months after discontinuation of all TKI among randomized patients). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05413915.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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