Chronic Myelogenous LeukemiaPhase 4NCT04877522
Asciminib Roll-over Study
A Phase 4 study testing Asciminib single agent, Imatinib and Nilotinib in people with Chronic Myelogenous Leukemia and Leukemia, Myelogenous, Chronic, BCR-ABL Positive, run by Novartis Pharmaceuticals at 85 sites in 29 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 7 to 100 years
- Conditions the study is for
- Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- What is being tested?
- Asciminib single agent, Imatinib and Nilotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 85 sitesin 29 countries
- Study dates
- 30 Aug 2022to 30 Aug 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- Participant has been discontinued from parent study treatment.
- Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
- Participant's ongoing treatment is currently approved and reimbursed at country level.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
- Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
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- 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.
Trial locations and contacts
85 sites in 29 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
85 sites in 29 countries
China12 sites, 9 recruiting
- Active, not recruiting
Novartis Investigative Site
Beijing, 100044
- Recruiting
Novartis Investigative Site
Beijing, 100730
- Recruiting
Novartis Investigative Site
Changchun, Jilin, 130021
- Completed
Novartis Investigative Site
Chengdu, Sichuan, 610041
- Recruiting
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400010
- Recruiting
Novartis Investigative Site
Guangzhou, Guangdong, 510515
- Active, not recruiting
Novartis Investigative Site
Shanghai, 200025
- Recruiting
Novartis Investigative Site
Shenyang, 110004
- Recruiting
Novartis Investigative Site
Tianjin, 300020
- Recruiting
Novartis Investigative Site
Wuhan, Hubei, 430022
- Recruiting
Novartis Investigative Site
Xian, Shanxi, 710004
- Recruiting
Novartis Investigative Site
Zhengzhou, Henan, 450008
Spain12 sites, 9 recruiting
- Recruiting
Novartis Investigative Site
Badalona, Barcelona, 08916
- Recruiting
Novartis Investigative Site
Barcelona, 08035
- Completed
Novartis Investigative Site
Barcelona, 08036
- Recruiting
Novartis Investigative Site
Bilbao, Bizkaia, 48013
- Completed
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
- Recruiting
Novartis Investigative Site
Madrid, 28006
- Completed
Novartis Investigative Site
Madrid, 28034
- Recruiting
Novartis Investigative Site
Madrid, 28041
- Recruiting
Novartis Investigative Site
Santa Cruz, Santa Cruz De Tenerife, 38009
- Recruiting
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
- Recruiting
Novartis Investigative Site
Seville, 41009
- Recruiting
Novartis Investigative Site
Valencia, 46026
United States6 sites, 5 recruiting
- Recruiting
Michigan Med University of Michigan
Ann Arbor, Michigan, 48109 5271
Kelly Whitley, kwhitley@med.umich.edu
Moshe Talpaz
- Recruiting
Texas Oncology
Dallas, Texas, 75251
Jessica Maner, +1 214 370 1000, Jessica.Maner@usoncology.com
Moshe Yair Levy
- Recruiting
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
Susan Aline Wahl, +1 713 792 2921, sawahl2@mdanderson.org
Fadi Haddad
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Esta Konkol, 414-805-6803, ekonkol@mcw.edu
Ehab Atallah
- Recruiting
Memorial Sloan Kettering
New York, New York, 10017
Shakira Pascual, 646-497-9068, pascuals@mskcc.org
Michael Mauro
- Active, not recruiting
Oregon Health Sciences University
Portland, Oregon, 97239
France6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Bordeaux, 33076
- Recruiting
Novartis Investigative Site
Lyon, 69373
- Recruiting
Novartis Investigative Site
Marseille, 13273
- Recruiting
Novartis Investigative Site
Nantes, 44093
- Recruiting
Novartis Investigative Site
Paris, 75475
- Recruiting
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Germany4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Berlin, 13353
- Recruiting
Novartis Investigative Site
Frankfurt am Main, Hesse, 60590
- Recruiting
Novartis Investigative Site
Jena, Thuringia, 07740
- Recruiting
Novartis Investigative Site
Kiel, 24116
Poland4 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Katowice, 40-519
- Completed
Novartis Investigative Site
Krakow, 30-688
- Recruiting
Novartis Investigative Site
Warsaw, 00-791
- Completed
Novartis Investigative Site
Wroclaw, 50 367
Russia4 sites, 2 recruiting
- Active, not recruiting
Novartis Investigative Site
Moscow, 125167
- Active, not recruiting
Novartis Investigative Site
Moscow, 125284
- Recruiting
Novartis Investigative Site
Saint Petersburg, 191024
- Recruiting
Novartis Investigative Site
Saint Petersburg, 197341
South Korea4 sites, 1 recruiting
- Completed
Novartis Investigative Site
Busan, 49201
- Completed
Novartis Investigative Site
Jeollanam, 519763
- Recruiting
Novartis Investigative Site
Seoul, 03080
- Active, not recruiting
Novartis Investigative Site
Uijeongbu-si, Gyeonggi-do, 11759
Brazil3 sites
- Completed
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20211-030
- Completed
Novartis Investigative Site
São Paulo, São Paulo, 05403 000
- Completed
Novartis Investigative Site
São Paulo, São Paulo, 08270-070
Italy3 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Milan, MI, 20162
- Completed
Novartis Investigative Site
Naples, 80131
- Recruiting
Novartis Investigative Site
Roma, RM, 00161
Malaysia3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
George Town, Pulau Pinang, 10450
- Recruiting
Novartis Investigative Site
Johor Bahru, 80100
- Recruiting
Novartis Investigative Site
Kuala Selangor, 68000
Argentina2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
CABA, Buenos Aires, C1221ADC
- Recruiting
Novartis Investigative Site
Capital Federal, C1114AAN
Austria2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Graz, 8036
- Recruiting
Novartis Investigative Site
Vienna, 1140
Czechia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Brno, 625 00
- Recruiting
Novartis Investigative Site
Ostrava, Poruba, 708 52
Portugal2 sites, 1 recruiting
- Active, not recruiting
Novartis Investigative Site
Lisbon, 1099-023
- Recruiting
Novartis Investigative Site
Porto, 4200-072
United Kingdom2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
London, W12 0HS
- Recruiting
Novartis Investigative Site
Oxford, OX3 7LE
Vietnam2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Hanoi, 100000
- Recruiting
Novartis Investigative Site
Ho Chi Minh City, 70000
Bulgaria1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Varna, 9000
Canada1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Japan1 site
- Active, not recruiting
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Mexico1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Monterrey, Nuevo León, 64460
Singapore1 site
- Active, not recruiting
Novartis Investigative Site
Singapore, 169608
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Samsun, Atakum, 55200
About this study
Official title: 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
Read the 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.
- Being tested
- Asciminib single agent, Imatinib, Nilotinib, Bosutinib, Dasatinib
- Keywords
- Chronic Myelogenous Leukemia, CML, ALL, CML-AP, CML-BP, CML-CP, myeloproliferative neoplasm, chronic phase, accelerated phase, blast phase, ABL001, asciminib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myeloproliferative Disorders, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asciminib single agentDrug
Also called ABL001
Taken orally, twice daily (BID) or once daily (QD), in fasting state
ImatinibDrug
Also called STI571
Taken orally, once daily, in the morning with low-fat meal
NilotinibDrug
Also called AMN107
Taken orally, twice daily, on an empty stomach
BosutinibDrug
Taken orally, once daily, with food
DasatinibDrug
Also called Sprycel
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Asciminib single agent pediatric formulationDrug
Also called ABL001
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.
| Study group | Role | What they receive |
|---|---|---|
| Asciminib single agent group | Experimental | 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 Receives: Drug: Asciminib single agent |
| Bosutinib single agent group | Other | Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib Receives: Drug: Bosutinib |
| Bosutinib-Asciminib switch group | Experimental | 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 Receives: Drug: Asciminib single agent |
| Asciminib in combination with imatinib group | Experimental | Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib Receives: Drug: Imatinib |
| Asciminib in combination with nilotinib group | Experimental | Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib Receives: Drug: Nilotinib |
| Imatinib single agent group | Other | Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib Receives: Drug: Imatinib |
| Nilotinib single agent group | Other | Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib Receives: Drug: Nilotinib |
| Asciminib in combination with dasatinib group | Experimental | Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib Receives: Drug: Dasatinib |
| Dasatinib single agent group | Other | Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib. Receives: Drug: Dasatinib |
| Dasatinib-Asciminib switch group | Experimental | 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 Receives: Drug: Asciminib single agent |
| Asciminib single agent formulation for Pediatric | Experimental | Participants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib Receives: Drug: Asciminib single agent pediatric formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
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.
Measured: 8 years
Secondary outcomes (1)
Percentage of participants with clinical benefit as assessed by Investigator
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.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start30 Aug 2022
- Primary completion30 Aug 2030 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 347 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877522
- Sponsor's protocol ID
- CABL001A2001B
- Other IDs
- 2021-000602-17, 2023-507557-16-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 4 May 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
- Expanded access
- Available