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Can a new pill outsmart leukemia that resists standard drugs?

NCT ID NCT03106779

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

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.

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

233 people

The number who actually took part.

Started

Oct 2017

Finished

Dec 2024

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 with a diagnosis of CML-CP ≥ 18 years of age Patients must meet all of the following laboratory values at the screening visit: * \< 15% blasts in peripheral blood and bone marrow * \< 30% blasts plus promyelocytes in peripheral blood and bone marrow * \< 20% basophils in the peripheral blood * ≥ 50 x 109/L (≥ 50,000/mm3) platelets * Transient prior therapy related thrombocytopenia (\< 50,000/mm3 for ≤ 30 days prior to screening) is acceptable * No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly BCR-ABL1 ratio \> 0.1% IS according to central laboratory at the screening examination for patients intolerant to the most recent TKI therapy Prior treatment with a minimum of 2 prior ATP-binding site TKIs (i.e. imatinib, nilotinib, dasatinib, radotinib or ponatinib) Failure (adapted from the 2013 ELN Guidelines Bacarrani 2013) or intolerance to the most recent TKI therapy at the time of screening * Failure is defined for CML-CP patients (CP at the time of initiation of last therapy) as follows. Patients must meet at least 1 of the following criteria. * Three months after the initiation of therapy: No CHR or \> 95% Ph+ metaphases * Six months after the initiation of therapy: BCR-ABL1 ratio \> 10% IS and/or \> 65% Ph+ metaphases * Twelve months after initiation of therapy: BCR-ABL1 ratio \> 10% IS and/or \> 35% Ph+ metaphases * At any time after the initiation of therapy, loss of CHR, CCyR or PCyR * At any time after the initiation of therapy, the development of new BCR-ABL1 mutations which potentially cause resistance to study treatment * At any time after the initiation of therapy, confirmed loss of MMR in 2 consecutive tests, of which one must have a BCR-ABL1 ratio ≥ 1% IS * At any time after the initiation of therapy, new clonal chromosome abnormalities in Ph+ cells: CCA/Ph+ * Intolerance is defined as: * Non-hematologic intolerance: Patients with grade 3 or 4 toxicity while on therapy, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal) * Hematologic intolerance: Patients with grade 3 or 4 toxicity (absolute neutrophil count \[ANC\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses recommended by manufacturer Exclusion Criteria: Known presence of the T315I or V299L 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 Cardiac or cardiac repolarization abnormality, including any of the following: * History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block) * QTcF at screening ≥450 msec (male patients), ≥460 msec (female patients) * 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 (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia * Concomitant medication(s) with a known risk of Torsades de Pointes per www.crediblemeds.org that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication. * Inability to determine the QTcF interval * 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, pulmonary hypertension) * History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis * History of acute or chronic liver disease * Treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with study treatment * Moderate or strong inducers of CYP3A * Moderate or strong inhibitors of CYP3A * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 days after last dose of ABL001 and one month after last dose of bosutinib. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception * Female sterilization (have had surgical bilateral oophorectomy (with or without hysterectomy) total hysterectomy or bilateral 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 by follow up hormone level assessment * Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject. * Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception. * In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. * Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking study medication. In the case of oophorectomy alone, women are considered post-menopausal and not of child bearing potential only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.

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