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New combo pill shows promise for stubborn leukemia

NCT ID NCT03578367

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether adding asciminib to the standard drug imatinib helps people with chronic myeloid leukemia (CML) achieve deeper remission. 104 adults who had been on imatinib for at least a year without reaching very low cancer levels were randomly assigned to add asciminib, stay on imatinib alone, or switch to nilotinib. The goal was to see if the combination leads to better molecular responses at 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
asciminib (ABL001) added to imatinib, compared to imatinib alone or nilotinib
What this could lead to
If it works, this could offer a new combination treatment to help CML patients who haven't reached very low levels of leukemia cells with standard therapy.
What could go wrong
This is a small, early-phase trial (104 people) with no long-term results yet. The added drug may cause more side effects or not improve outcomes significantly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

104 people

The number who actually took part.

Started

Nov 2018

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patients ≥ 18 years of age with a confirmed diagnosis of CML-CP. * Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 400 mg QD at randomization and had no dose change in the past three months). For Korea only: (i) a minimum of one year (12 calendar months) of prior treatment with imatinib for patients with BCR::ABL1 levels \> 0.1%, ≤ 1% IS at the time of randomization. (ii) a minimum of two years (24 calendar months) of prior treatment with imatinib for patients with BCR::ABL 1 levels \> 0.01%, ≤ 0.1% IS at the time of randomization. * BCR::ABL1 levels \> 0.01% IS (International Scale) and ≤ 1% IS at the time of randomization as confirmed with a central assessment at screening; patients must not have achieved deep molecular response (MR4 IS) confirmed by 2 consecutive tests at any time during prior imatinib treatment. An isolated, single test result with BCR::ABL1 levels \< 0.01 % (MR4 IS) is allowed, however, it should not have been observed within the 9 months prior to randomization * Patient must meet the following laboratory values before randomization: * Absolute Neutrophil Count ≥ 1.5 x 10E9/L * Platelets ≥ 75 x 10E9/L * Hemoglobin ≥ 9 g/dL * Serum creatinine \< 1.5 mg/dL * Total bilirubin ≤ 1.5 x ULN (Upper Limit of Normal) 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 * Participants must have the following laboratory values ≥ Lower Limit of Normal or corrected to within normal limits with supplements prior to randomization: potassium increase of up to 6.0 mmol/L is acceptable if associated with creatinine clearance within normal limits ; calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with creatinine clearance\* within normal limits) ; magnesium increase up to 3.0 mg/dL or 1.23 mmol/L if associated with creatinine clearance within normal limits. Key Exclusion Criteria: * Treatment failure according to European Leukemia Network (ELN) criteria 2013 during imatinib treatment. * Known second chronic phase of CML after previous progression to Accelerated Phase (AP)/Blast Crisis (BC). * Previous treatment with any tyrosine kinase inhibitors (TKIs) other than imatinib. * History or current diagnosis of ECG abnormalities indicating significant risk or safety for participants 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 * Concomitant medications with a "known" risk of Torsades de Pointes * inability to determine the QTcF interval 5. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant hyperlipidemia and high serum amylase) 6. 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 7. History of other active malignancy within 3 years prior to randomization with the exception of basal cell skin cancer, indolent prostate cancer and carcinoma in situ treated curatively.

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive hematologic disorder leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myelogenous leukemia CML Hematologic diseases Leukemia,myeloid, chronic

Contacts and locations

Locations

  • Georgia Regents University

    Augusta, Georgia, 30912, United States

  • Novartis Investigative Site

    Vienna, 1140, Austria

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4, Canada

  • Novartis Investigative Site

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    Copenhagen, DK-2100, Denmark

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Roma, RM, 00161, Italy

  • Novartis Investigative Site

    Krakow, 31 531, Poland

  • Novartis Investigative Site

    Warsaw, 00-791, Poland

  • Novartis Investigative Site

    Wroclaw, 50 367, Poland

  • Novartis Investigative Site

    Lisbon, 1099-023, Portugal

  • Novartis Investigative Site

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    Moscow, 125167, Russia

  • Novartis Investigative Site

    Moscow, 125284, Russia

  • Novartis Investigative Site

    Saint Petersburg, 191024, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197341, Russia

  • Novartis Investigative Site

    Uijeongbu-si, Gyeonggi-do, 11759, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Seville, 41009, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Changhua, 50006, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Liverpool, CH63 4JY, United Kingdom

  • Novartis Investigative Site

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    Oxford, OX3 7LE, United Kingdom

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21205, United States

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