New combo pill shows promise for stubborn leukemia

NCT ID NCT03578367

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

First seen Jun 24, 2026 · Last updated Jun 24, 2026

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.

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Contacts and locations

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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

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.

Conditions

The condition(s) this trial relates to.

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