Can a new pill outsmart leukemia that resists standard drugs?

NCT ID NCT03106779

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

First seen Aug 18, 2026 · Last updated Aug 18, 2026

Summary

This trial compares two oral medications for adults with chronic myeloid leukemia (CML) in its chronic phase who have already been treated with at least two other targeted therapies. Participants receive either the experimental drug asciminib or the existing drug bosutinib. The goal is to see if asciminib can achieve a major molecular response—a deep reduction in leukemia-related genetic material—more effectively than bosutinib.

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), an experimental oral drug, compared against bosutinib, an existing oral drug
What this could lead to: If asciminib works better, it could offer a new, more effective oral option for people with CML who have already tried other treatments.
What could go wrong: This is a phase 3 trial, but success is not guaranteed. Asciminib may not prove superior to bosutinib, and side effects could limit its use.

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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

Dana Farber Cancer Center

Boston, Massachusetts, 02215, United States
Indiana Blood and Marrow Institute

Beech Grove, Indiana, 46107, United States
Memorial Sloan Kettering Cancer Ctr

New York, New York, 10065, United States
Novartis Investigative Site

CABA, Buenos Aires, C1221ADH, Argentina
Novartis Investigative Site

Capital Federal, C1114AAN, Argentina
Novartis Investigative Site

Córdoba, X5016KEH, Argentina
Novartis Investigative Site

Adelaide, South Australia, 5000, Australia
Novartis Investigative Site

Melbourne, Victoria, 3000, Australia
Novartis Investigative Site

Murdoch, Western Australia, 6150, Australia
Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 20211-030, Brazil
Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Novartis Investigative Site

São Paulo, São Paulo, 05403 000, Brazil
Novartis Investigative Site

São Paulo, São Paulo, 08270-070, Brazil
Novartis Investigative Site

Plovdiv, 4002, Bulgaria
Novartis Investigative Site

Varna, 9000, Bulgaria
Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada
Novartis Investigative Site

Ostrava, Poruba, 708 52, Czechia
Novartis Investigative Site

Brno, 625 00, Czechia
Novartis Investigative Site

Bordeaux, 33076, France
Novartis Investigative Site

Lyon, 69373, France
Novartis Investigative Site

Marseille, 13273, France
Novartis Investigative Site

Paris, 75475, France
Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France
Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 68305, Germany
Novartis Investigative Site

Frankfurt am Main, Hesse, 60590, Germany
Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, 40225, Germany
Novartis Investigative Site

Jena, Thuringia, 07740, Germany
Novartis Investigative Site

Berlin, 13353, Germany
Novartis Investigative Site

Heidelberg, 69120, Germany
Novartis Investigative Site

Kiel, 24116, Germany
Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary
Novartis Investigative Site

Budapest, H-1097, Hungary
Novartis Investigative Site

Jerusalem, 9112001, Israel
Novartis Investigative Site

Ẕerifin, 7030000, Israel
Novartis Investigative Site

Bari, BA, 70124, Italy
Novartis Investigative Site

Milan, MI, 20122, Italy
Novartis Investigative Site

Naples, 80131, Italy
Novartis Investigative Site

Nagoya, Aichi-ken, 453-8511, Japan
Novartis Investigative Site

Toyoake, Aichi-ken, 4701192, Japan
Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan
Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan
Novartis Investigative Site

Sakai, Osaka, 590-0197, Japan
Novartis Investigative Site

Suita, Osaka, 5650871, Japan
Novartis Investigative Site

Bunkyo Ku, Tokyo, 1138677, Japan
Novartis Investigative Site

Chūō, Yamanashi, 409-3898, Japan
Novartis Investigative Site

Akita, 0108543, Japan
Novartis Investigative Site

Aomori, 0308553, Japan
Novartis Investigative Site

Beirut, 1100 2070, Lebanon
Novartis Investigative Site

Beirut, 113-0236, Lebanon
Novartis Investigative Site

Monterrey, Nuevo León, 64460, Mexico
Novartis Investigative Site

Amsterdam, North Holland, 1081 HV, Netherlands
Novartis Investigative Site

Dordrecht, South Holland, 3318 AT, Netherlands
Novartis Investigative Site

Cluj-Napoca, Cluj, 400015, Romania
Novartis Investigative Site

Timișoara, 300079, Romania
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

Riyadh, 11211, Saudi Arabia
Novartis Investigative Site

Belgrade, 11000, Serbia
Novartis Investigative Site

Novi Sad, 400107, Serbia
Novartis Investigative Site

Uijeongbu-si, Gyeonggi-do, 11759, South Korea
Novartis Investigative Site

Busan, 49201, South Korea
Novartis Investigative Site

Jeollanam, 519763, South Korea
Novartis Investigative Site

Seoul, 06591, South Korea
Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Novartis Investigative Site

Bilbao, Bizkaia, 48013, Spain
Novartis Investigative Site

Toledo, Castille-La Mancha, 45071, Spain
Novartis Investigative Site

Barcelona, 08036, Spain
Novartis Investigative Site

Madrid, 28034, Spain
Novartis Investigative Site

Zurich, 8091, Switzerland
Novartis Investigative Site

Samsun, Atakum, 55200, Turkey (Türkiye)
Novartis Investigative Site

Istanbul, Fatih, 34093, Turkey (Türkiye)
Novartis Investigative Site

Istanbul, Fatih, 34098, Turkey (Türkiye)
Novartis Investigative Site

Adana, Saricam, 01330, Turkey (Türkiye)
Novartis Investigative Site

Izmir, 35100, Turkey (Türkiye)
Novartis Investigative Site

Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom
Novartis Investigative Site

Cardiff, CF14 4XW, United Kingdom
Novartis Investigative Site

Glasgow, G12 0YN, United Kingdom
Novartis Investigative Site

London, W12 0HS, United Kingdom
Novartis Investigative Site

Oxford, OX3 7LE, United Kingdom
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States
Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, 77030, United States
University of Chicago Hospital

Chicago, Illinois, 60637, United States
University of Michigan Clinical Trials Office

Ann Arbor, Michigan, 48109, United States
Utah Huntsman Cancer Center

Salt Lake City, Utah, 84112, United States
Weill Cornell Medicine NY-Presb

New York, New York, 10021, United States

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