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Leukemia drug Asciminib's Long-Term safety tracked in ongoing study

NCT ID NCT04877522

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This study follows people with chronic myeloid leukemia (CML) who have already benefited from the drug asciminib in earlier Novartis trials. Researchers want to see how safe the drug is over the long term. About 347 participants will continue taking asciminib or other similar drugs and be monitored for side effects. No new treatment is being tested—this is about checking safety for those already on the medication.

What this could mean

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

Active substance
Asciminib (also known as ABL001), imatinib, nilotinib, bosutinib, dasatinib
What this could lead to
If successful, this study will confirm that long-term use of asciminib is safe for controlling chronic myeloid leukemia.
What could go wrong
This is an observational roll-over study, not a test of a new treatment. It only includes patients already benefiting, so results may not apply to everyone. Side effects are still possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 347 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Aug 2030

An estimate. End dates often move.

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

7 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.

Key Inclusion Criteria: 1. Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment. 2. Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures. Key Exclusion Criteria: 1. Participant has been discontinued from parent study treatment. 2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study. 3. Participant's ongoing treatment is currently approved and reimbursed at country level. 4. Pregnant or nursing (lactating) women. 5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment. 6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information. 7. Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment: * Asymptomatic (grade 2) pancreatitis if not resolved within 28 days * QTcF\>480msec or inability to determine QTc interval * any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment Other protocol-defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) blast phase chronic myelogenous leukemia, BCR-ABL1 positive chronic myelogenous leukemia, BCR-ABL1 positive leukemia, acute lymphocytic, susceptibility to, 1 Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myeloproliferative Disorders

As listed by the trial registrant

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

Chronic myelogenous leukemia Leukemia, myelogenous, chronic, BCR-ABL positive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    59 sites in 21 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering

    RECRUITING

    New York, New York, 10017, United States

  • Michigan Med University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109 5271, United States

  • Novartis Investigative Site

    RECRUITING

    CABA, Buenos Aires, C1221ADC, Argentina

  • Novartis Investigative Site

    RECRUITING

    Capital Federal, C1114AAN, Argentina

  • Novartis Investigative Site

    RECRUITING

    Graz, 8036, Austria

  • Novartis Investigative Site

    RECRUITING

    Vienna, 1140, Austria

  • Novartis Investigative Site

    COMPLETED

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

  • Novartis Investigative Site

    COMPLETED

    São Paulo, São Paulo, 05403 000, Brazil

  • Novartis Investigative Site

    COMPLETED

    São Paulo, São Paulo, 08270-070, Brazil

  • Novartis Investigative Site

    RECRUITING

    Varna, 9000, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Novartis Investigative Site

    RECRUITING

    Chongqing, Chongqing Municipality, 400010, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    RECRUITING

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    RECRUITING

    Xian, Shanxi, 710004, China

  • Novartis Investigative Site

    COMPLETED

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Beijing, 100044, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Shanghai, 200025, China

  • Novartis Investigative Site

    RECRUITING

    Shenyang, 110004, China

  • Novartis Investigative Site

    RECRUITING

    Tianjin, 300020, China

  • Novartis Investigative Site

    RECRUITING

    Ostrava, Poruba, 708 52, Czechia

  • Novartis Investigative Site

    RECRUITING

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    COMPLETED

    Copenhagen, DK-2100, Denmark

  • Novartis Investigative Site

    RECRUITING

    Bordeaux, 33076, France

  • Novartis Investigative Site

    RECRUITING

    Lyon, 69373, France

  • Novartis Investigative Site

    RECRUITING

    Marseille, 13273, France

  • Novartis Investigative Site

    RECRUITING

    Nantes, 44093, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75475, France

  • Novartis Investigative Site

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    RECRUITING

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 13353, Germany

  • Novartis Investigative Site

    RECRUITING

    Kiel, 24116, Germany

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00161, Italy

  • Novartis Investigative Site

    COMPLETED

    Naples, 80131, Italy

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

  • Novartis Investigative Site

    COMPLETED

    Beirut, 113-0236, Lebanon

  • Novartis Investigative Site

    RECRUITING

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Johor Bahru, 80100, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Kuala Selangor, 68000, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    RECRUITING

    Khoudh, 123, Oman

  • Novartis Investigative Site

    RECRUITING

    Katowice, 40-519, Poland

  • Novartis Investigative Site

    COMPLETED

    Krakow, 30-688, Poland

  • Novartis Investigative Site

    RECRUITING

    Warsaw, 00-791, Poland

  • Novartis Investigative Site

    COMPLETED

    Wroclaw, 50 367, Poland

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Lisbon, 1099-023, Portugal

  • Novartis Investigative Site

    RECRUITING

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    COMPLETED

    Timișoara, 300079, Romania

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Moscow, 125167, Russia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Moscow, 125284, Russia

  • Novartis Investigative Site

    RECRUITING

    Saint Petersburg, 191024, Russia

  • Novartis Investigative Site

    RECRUITING

    Saint Petersburg, 197341, Russia

  • Novartis Investigative Site

    COMPLETED

    Riyadh, 11211, Saudi Arabia

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

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

  • Novartis Investigative Site

    COMPLETED

    Busan, 49201, South Korea

  • Novartis Investigative Site

    COMPLETED

    Jeollanam, 519763, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    COMPLETED

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    RECRUITING

    Bilbao, Bizkaia, 48013, Spain

  • Novartis Investigative Site

    RECRUITING

    Santa Cruz, Santa Cruz De Tenerife, 38009, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    COMPLETED

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28006, Spain

  • Novartis Investigative Site

    COMPLETED

    Madrid, 28034, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Seville, 41009, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46026, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Hanoi, 100000, Vietnam

  • Novartis Investigative Site

    RECRUITING

    Ho Chi Minh City, 70000, Vietnam

  • Oregon Health Sciences University

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97239, United States

  • Texas Oncology

    RECRUITING

    Dallas, Texas, 75251, United States

  • Uni Of TX MD Anderson Cancer Cntr

    RECRUITING

    Houston, Texas, 77030, United States

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