Asciminib Roll-over Study

Last updated: April 22, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Leukemia

Chronic Myeloid Leukemia

Treatment

Nilotinib

Asciminib

Bosutinib

Clinical Study ID

NCT04877522
CABL001A2001B
2021-000602-17
2023-507557-16-00
  • Ages 18-100
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 opinionof the Investigator, would benefit from continued treatment.

  2. Participant has demonstrated compliance on the parent study protocol and is willingand able to comply with scheduled visits, treatment plans and any other studyprocedures.

Exclusion

Key Exclusion Criteria:

  1. Participant has been discontinued from parent study treatment.

  2. Participant currently has unresolved toxicities reported as possibly related tostudy treatment in the parent study.

  3. Participant's ongoing treatment is currently approved and reimbursed at countrylevel.

  4. Pregnant or nursing (lactating) women.

  5. Women of child-bearing potential, unless they are using highly effective methods ofcontraception and willing to continue while taking study treatment.

  6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinibunwilling to follow the relevant contraception requirements in the local prescribinginformation.

  7. Applicable for participants on bosutinib treatment at the end of the CABL001A2301and 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 daysbefore starting asciminib treatment

Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 347
Treatment Group(s): 6
Primary Treatment: Nilotinib
Phase: 4
Study Start date:
August 30, 2022
Estimated Completion Date:
August 30, 2030

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Caba, Buenos Aires C1221ADC
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Graz, 8036
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Wien, 1140
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Rio de Janeiro, RJ 20211-030
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Paulo, SP 08270-070
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Varna, 9000
    Bulgaria

    Active - Recruiting

  • Novartis Investigative Site

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Chongqing, Chongqing 400010
    China

    Active - Recruiting

  • Novartis Investigative Site

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Novartis Investigative Site

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Novartis Investigative Site

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Novartis Investigative Site

    Chang Chun, Jilin 130021
    China

    Active - Recruiting

  • Novartis Investigative Site

    Xian, Shanxi 710004
    China

    Active - Recruiting

  • Novartis Investigative Site

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Novartis Investigative Site

    Beijing, 100730
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shanghai, 200025
    China

    Site Not Available

  • Novartis Investigative Site

    Shenyang, 110004
    China

    Active - Recruiting

  • Novartis Investigative Site

    Tianjin, 300020
    China

    Active - Recruiting

  • Novartis Investigative Site

    Ostrava, Poruba 708 52
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Brno Bohunice, 625 00
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Brno-Bohunice, 639 00
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Copenhagen, DK-2100
    Denmark

    Active - Recruiting

  • Novartis Investigative Site

    Kobenhavn O, DK-2100
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Bordeaux, 33076
    France

    Active - Recruiting

  • Novartis Investigative Site

    Lyon, 69373
    France

    Active - Recruiting

  • Novartis Investigative Site

    Marseille, 13273
    France

    Active - Recruiting

  • Novartis Investigative Site

    Nantes Cedex 1, 44093
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris 10, 75475
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris Cedex 10, 75475
    France

    Site Not Available

  • Novartis Investigative Site

    Vandoeuvre Les Nancy, 54511
    France

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt am Main, Hessen 60590
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jena, 07740
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Kiel, 24116
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Milano, MI 20162
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Roma, RM 00161
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Napoli, 80132
    Italy

    Completed

  • Novartis Investigative Site

    Kobe shi, 650-0017
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe-shi, 650-0017
    Japan

    Site Not Available

  • Novartis Investigative Site

    Uijeongbu si, Gyeonggi Do 11759
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Busan, 49201
    Korea, Republic of

    Completed

  • Novartis Investigative Site

    Jeollanam, 519763
    Korea, Republic of

    Completed

  • Novartis Investigative Site

    Jeollanam-do, 519763
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Beirut, 1107 2020
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Johor Bahru, 80100
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Pulau Pinang, 10990
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Selangor, 68000
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Monterrey, Nuevo Leon 64460
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Krakow, 30-688
    Poland

    Site Not Available

  • Novartis Investigative Site

    Warszawa, 00-791
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Wroclaw, 50 367
    Poland

    Completed

  • Novartis Investigative Site

    Lisboa, 1099 023
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Porto, 4200-072
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Timisoara, 300079
    Romania

    Active - Recruiting

  • Novartis Investigative Site

    Moscow, 125284
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg, 197341
    Russian Federation

    Active - Recruiting

  • Novartis Investigative Site

    St Petersburg, 191024
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Riyadh, 11211
    Saudi Arabia

    Site Not Available

  • Novartis Investigative Site

    Singapore, 169608
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Sevilla, Andalucia 41009
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Badalona, Catalunya 08916
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Barcelona, Catalunya 08036
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Hospitalet de LLobregat, Catalunya 08907
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Santiago De Compostela, Galicia 15706
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Bilbao, Pais Vasco 48013
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Santa Cruz de Tenerife, 38009
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Valencia, 46026
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Taoyuan, 33305
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Samsun, 55139
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Oxford, OX3 7LE
    United Kingdom

    Active - Recruiting

  • Michigan Med University of Michigan

    Ann Arbor, Michigan 48109 5271
    United States

    Active - Recruiting

  • Michigan Med University of Michigan .

    Ann Arbor, Michigan 48109 5271
    United States

    Active - Recruiting

  • Michigan Medicine University of Michigan

    Ann Arbor, Michigan 48109 5271
    United States

    Active - Recruiting

  • Memorial Sloan Kettering

    New York, New York 10017
    United States

    Active - Recruiting

  • Oregon Health Sciences University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health Sciences University .

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science Univ

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Uni Of TX MD Anderson Cancer Cntr

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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