Asciminib Roll-over Study

May 8, 2026 updated by: Novartis Pharmaceuticals

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.

Study Type

Interventional

Enrollment (Estimated)

347

Phase

  • Phase 4

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Capital Federal, Argentina, C1114AAN
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1221ADC
        • Recruiting
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Novartis Investigative Site
      • Vienna, Austria, 1140
        • Recruiting
        • Novartis Investigative Site
  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20211-030
        • Completed
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403 000
        • Completed
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 08270-070
        • Completed
        • Novartis Investigative Site
  • Bulgaria
      • Varna, Bulgaria, 9000
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Recruiting
        • Novartis Investigative Site
      • Beijing, China, 100044
        • Active, not recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Active, not recruiting
        • Novartis Investigative Site
      • Shenyang, China, 110004
        • Recruiting
        • Novartis Investigative Site
      • Tianjin, China, 300020
        • Recruiting
        • Novartis Investigative Site
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Novartis Investigative Site
    • Shanxi
      • Xian, Shanxi, China, 710004
        • Recruiting
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Completed
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 625 00
        • Recruiting
        • Novartis Investigative Site
    • Poruba
      • Ostrava, Poruba, Czechia, 708 52
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Completed
        • Novartis Investigative Site
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Novartis Investigative Site
      • Lyon, France, 69373
        • Recruiting
        • Novartis Investigative Site
      • Marseille, France, 13273
        • Recruiting
        • Novartis Investigative Site
      • Nantes, France, 44093
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75475
        • Recruiting
        • Novartis Investigative Site
      • Vandœuvre-lès-Nancy, France, 54511
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
      • Kiel, Germany, 24116
        • Recruiting
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Recruiting
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Germany, 07740
        • Recruiting
        • Novartis Investigative Site
  • Italy
      • Naples, Italy, 80131
        • Completed
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20162
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00161
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Kobe, Japan, 650-0017
        • Active, not recruiting
        • Novartis Investigative Site
  • Lebanon
      • Beirut, Lebanon, 113-0236
        • Completed
        • Novartis Investigative Site
  • Malaysia
      • Johor Bahru, Malaysia, 80100
        • Recruiting
        • Novartis Investigative Site
      • Kuala Selangor, Malaysia, 68000
        • Recruiting
        • Novartis Investigative Site
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Recruiting
        • Novartis Investigative Site
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Novartis Investigative Site
  • Oman
      • Khoudh, Oman, 123
        • Recruiting
        • Novartis Investigative Site
  • Poland
      • Katowice, Poland, 40-519
        • Recruiting
        • Novartis Investigative Site
      • Krakow, Poland, 30-688
        • Completed
        • Novartis Investigative Site
      • Warsaw, Poland, 00-791
        • Recruiting
        • Novartis Investigative Site
      • Wroclaw, Poland, 50 367
        • Completed
        • Novartis Investigative Site
  • Portugal
      • Lisbon, Portugal, 1099-023
        • Active, not recruiting
        • Novartis Investigative Site
      • Porto, Portugal, 4200-072
        • Recruiting
        • Novartis Investigative Site
  • Romania
      • Timișoara, Romania, 300079
        • Completed
        • Novartis Investigative Site
  • Russia
      • Moscow, Russia, 125284
        • Active, not recruiting
        • Novartis Investigative Site
      • Moscow, Russia, 125167
        • Active, not recruiting
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 191024
        • Recruiting
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197341
        • Recruiting
        • Novartis Investigative Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • Completed
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Active, not recruiting
        • Novartis Investigative Site
  • South Korea
      • Busan, South Korea, 49201
        • Completed
        • Novartis Investigative Site
      • Jeollanam, South Korea, 519763
        • Completed
        • Novartis Investigative Site
      • Seoul, South Korea, 03080
        • Recruiting
        • Novartis Investigative Site
    • Gyeonggi-do
      • Uijeongbu-si, Gyeonggi-do, South Korea, 11759
        • Active, not recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
      • Barcelona, Spain, 08036
        • Completed
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Completed
        • Novartis Investigative Site
      • Seville, Spain, 41009
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Recruiting
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spain, 15706
        • Recruiting
        • Novartis Investigative Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Novartis Investigative Site
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Novartis Investigative Site
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48013
        • Recruiting
        • Novartis Investigative Site
    • Santa Cruz De Tenerife
      • Santa Cruz, Santa Cruz De Tenerife, Spain, 38009
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Taoyuan, Taiwan, 33305
        • Active, not recruiting
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Atakum
      • Samsun, Atakum, Turkey (Türkiye), 55200
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Novartis Investigative Site
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109 5271
        • Recruiting
        • Michigan Med University of Michigan
        • Principal Investigator:
          • Moshe Talpaz
        • Contact:
    • New York
      • New York, New York, United States, 10017
        • Recruiting
        • Memorial Sloan Kettering
        • Principal Investigator:
          • Michael Mauro
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Active, not recruiting
        • Oregon Health Sciences University
    • Texas
      • Dallas, Texas, United States, 75251
        • Recruiting
        • Texas Oncology
        • Principal Investigator:
          • Moshe Yair Levy
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Uni Of TX MD Anderson Cancer Cntr
        • Contact:
        • Principal Investigator:
          • Fadi Haddad
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Recruiting
        • Novartis Investigative Site
      • Ho Chi Minh City, Vietnam, 70000
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Asciminib single agent group
Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to CABL001A2301, CABL001A2302, CABL001X2101, CABL001A2202, CABL001AUS04 and CABL001AUS08 studies, that were receiving asciminib
Drug: Asciminib single agent
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Other Names:
  • ABL001
Other: Bosutinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib
Drug: Bosutinib
Taken orally, once daily, with food
Experimental: Bosutinib-Asciminib switch group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study
Drug: Asciminib single agent
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Other Names:
  • ABL001
Experimental: Asciminib in combination with imatinib group
Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
Drug: Imatinib
Taken orally, once daily, in the morning with low-fat meal
Other Names:
  • STI571
Experimental: Asciminib in combination with nilotinib group
Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib
Drug: Nilotinib
Taken orally, twice daily, on an empty stomach
Other Names:
  • AMN107
Other: Imatinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib
Drug: Imatinib
Taken orally, once daily, in the morning with low-fat meal
Other Names:
  • STI571
Other: Nilotinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib
Drug: Nilotinib
Taken orally, twice daily, on an empty stomach
Other Names:
  • AMN107
Experimental: Asciminib in combination with dasatinib group
Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib
Drug: Dasatinib
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Other Names:
  • Sprycel
Other: Dasatinib single agent group
Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
Drug: Dasatinib
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Other Names:
  • Sprycel
Experimental: Dasatinib-Asciminib switch group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2202 that were receiving best available therapy (dasatinib) and switched to asciminib when entering this study or during the course of this study
Drug: Asciminib single agent
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Other Names:
  • ABL001
Experimental: Asciminib single agent formulation for Pediatric
Participants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib
Drug: Asciminib single agent pediatric formulation
Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.
Other Names:
  • ABL001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 8 years
All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with clinical benefit as assessed by Investigator
Time Frame: 8 years
Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2022

Primary Completion (Estimated)

August 30, 2030

Study Completion (Estimated)

August 30, 2030

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CABL001A2001B
  • 2021-000602-17 (EudraCT Number)
  • 2023-507557-16-00 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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