Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for leukemia patients: asciminib shows promise in phase 3 trial

NCT ID NCT04948333

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug asciminib in 199 adults with chronic myeloid leukemia (CML) whose cancer was not well controlled after trying at least two other targeted therapies. The main goal was to see how many patients achieved a major molecular response (a key sign of disease control) after 48 weeks of treatment. The results help doctors understand how to best use asciminib for patients who need a new treatment option.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

199 people

The number who actually took part.

Started

Oct 2021

Finished

Feb 2026

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 99 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.

Key Inclusion criteria: * Signed informed consent must be obtained prior to participation in the study * Male or female patients with a diagnosis of CML-CP ≥ 18 years of age * Treatment with a minimum of 2 or more prior TKIs (i.e. imatinib, nilotinib, dasatinib, bosutinib, radotinib or ponatinib) * Warning or failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 * Adequate end organ function (as per central laboratory tests) Key Exclusion criteria: * Known presence of the BCR::ABL1 T315I mutation at any time prior to study entry * Known second chronic phase of CML after previous progression to AP/BC * Previous treatment with a hematopoietic stem-cell transplantation * Patient planning to undergo allogeneic hematopoietic stem cell transplantation * Uncontrolled cardiac repolarization abnormality * 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 * History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis * Testing for Hepatitis B surface antigen (HbsAg) and Hepatitis B core antibody (HBcAb / anti HBc) will be performed at screening. Patients with active Hepatitis B Virus (HBV) infection (hepatitis B surface antigen \[HbsAg\] positive) will be excluded Other Inclusion/Exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic myelogenous leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Chronic myelogenous leukemia

Contacts and locations

Locations

  • Novartis Investigative Site

    CABA, Buenos Aires, C1221ADC, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1114AAN, Argentina

  • Novartis Investigative Site

    Graz, 8036, Austria

  • Novartis Investigative Site

    Linz, 4010, Austria

  • Novartis Investigative Site

    Vienna, 1140, Austria

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20211-030, Brazil

  • Novartis Investigative Site

    São Paulo, 01227-200, Brazil

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Montpellier, 34295, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Kiel, 24116, Germany

  • Novartis Investigative Site

    München, 80377, Germany

  • Novartis Investigative Site

    Athens, 115 27, Greece

  • Novartis Investigative Site

    Thessaloniki, 570 10, Greece

  • Novartis Investigative Site

    Monza, MB, 20900, Italy

  • Novartis Investigative Site

    Roma, RM, 00161, Italy

  • Novartis Investigative Site

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Kota Kinabalu, Sabah, 88586, Malaysia

  • Novartis Investigative Site

    Johor Bahru, 80100, Malaysia

  • Novartis Investigative Site

    Kuala Selangor, 68000, Malaysia

  • Novartis Investigative Site

    Khoudh, 123, Oman

  • Novartis Investigative Site

    Katowice, 40-519, Poland

  • Novartis Investigative Site

    Warsaw, 00-791, Poland

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Seoul, Korea, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    Taegu, 41944, South Korea

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    Bilbao, Bizkaia, 48013, Spain

  • Novartis Investigative Site

    Santa Cruz, Santa Cruz De Tenerife, 38009, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Leeds, West Yorkshire, LS9 7TF, United Kingdom

  • Novartis Investigative Site

    Cambridge, CB2 0QQ, United Kingdom

  • Novartis Investigative Site

    London, SE1 9RT, United Kingdom

  • Novartis Investigative Site

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    Hanoi, 100000, Vietnam

  • Novartis Investigative Site

    Ho Chi Minh City, 70000, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.