Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Asciminib Roll-over-studie

6. november 2026 oppdatert av: Novartis Pharmaceuticals

En åpen etikett, multi-senter Asciminib Roll-over-studie for å vurdere langsiktig sikkerhet hos pasienter som har fullført en Novartis-sponsert asciminib-studie og som er bedømt av etterforskeren for å dra nytte av fortsatt behandling

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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

347

Fase

  • Fase 4

Utvidet tilgang

Tilgjengelig utenfor den kliniske utprøvingen. Se utvidet tilgangspost.

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

  • Argentina
      • Capital Federal, Argentina, C1114AAN
        • Rekruttering
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1221ADC
        • Rekruttering
        • Novartis Investigative Site
  • Brasil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasil, 20211-030
        • Fullført
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brasil, 08270-070
        • Fullført
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brasil, 05403-000
        • Fullført
        • Novartis Investigative Site
  • Bulgaria
      • Varna, Bulgaria, 9000
        • Rekruttering
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Rekruttering
        • Novartis Investigative Site
  • Danmark
      • Copenhagen, Danmark, 2100
        • Fullført
        • Novartis Investigative Site
  • Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-5271
        • Rekruttering
        • Michigan Med University of Michigan
        • Hovedetterforsker:
          • Moshe Talpaz
        • Ta kontakt med:
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Rekruttering
        • Washington University School Of Medicine-Siteman Cancer Ctr
        • Hovedetterforsker:
          • Iskra Pusic
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10017
        • Rekruttering
        • Memorial Sloan Kettering
        • Hovedetterforsker:
          • Michael Mauro
        • Ta kontakt med:
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45242
        • Rekruttering
        • Oncology Hematology Care Inc
        • Hovedetterforsker:
          • David Waterhouse
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Aktiv, ikke rekrutterende
        • Oregon Health Sciences University
    • Texas
      • Dallas, Texas, Forente stater, 75251
        • Rekruttering
        • Texas Oncology
        • Hovedetterforsker:
          • Moshe Yair Levy
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • Uni Of TX MD Anderson Cancer Cntr
        • Ta kontakt med:
        • Hovedetterforsker:
          • Fadi Haddad
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Rekruttering
        • Huntsman Cancer Institute
        • Hovedetterforsker:
          • Srinivas Tantravahi
        • Ta kontakt med:
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Rekruttering
        • Medical College of Wisconsin
        • Hovedetterforsker:
          • Ehab Atallah
        • Ta kontakt med:
  • Frankrike
      • Bordeaux, Frankrike, 33076
        • Rekruttering
        • Novartis Investigative Site
      • Lyon, Frankrike, 69373
        • Rekruttering
        • Novartis Investigative Site
      • Marseille, Frankrike, 13273
        • Rekruttering
        • Novartis Investigative Site
      • Nantes, Frankrike, 44093
        • Rekruttering
        • Novartis Investigative Site
      • Paris, Frankrike, 75475
        • Rekruttering
        • Novartis Investigative Site
      • Vandœuvre-lès-Nancy, Frankrike, 54511
        • Rekruttering
        • Novartis Investigative Site
  • Italia
      • Naples, Italia, 80131
        • Fullført
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italia, 20162
        • Rekruttering
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italia, 00161
        • Rekruttering
        • Novartis Investigative Site
  • Japan
    • Hyōgo
      • Kobe, Hyōgo, Japan, 6500017
        • Aktiv, ikke rekrutterende
        • Novartis Investigative Site
  • Kina
      • Beijing, Kina, 100730
        • Rekruttering
        • Novartis Investigative Site
      • Beijing, Kina, 100044
        • Aktiv, ikke rekrutterende
        • Novartis Investigative Site
      • Shanghai, Kina, 200025
        • Aktiv, ikke rekrutterende
        • Novartis Investigative Site
      • Shenyang, Kina, 110004
        • Rekruttering
        • Novartis Investigative Site
      • Tianjin, Kina, 300020
        • Rekruttering
        • Novartis Investigative Site
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400010
        • Rekruttering
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Rekruttering
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, Kina, 450008
        • Rekruttering
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • Rekruttering
        • Novartis Investigative Site
    • Shanxi
      • Xian, Shanxi, Kina, 710004
        • Rekruttering
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Fullført
        • Novartis Investigative Site
  • Libanon
      • Beirut, Libanon, 113-0236
        • Fullført
        • Novartis Investigative Site
  • Malaysia
      • Johor Bahru, Malaysia, 80100
        • Rekruttering
        • Novartis Investigative Site
      • Kuala Selangor, Malaysia, 68000
        • Rekruttering
        • Novartis Investigative Site
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Rekruttering
        • Novartis Investigative Site
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Rekruttering
        • Novartis Investigative Site
  • Oman
      • Khoudh, Oman, 123
        • Rekruttering
        • Novartis Investigative Site
  • Polen
      • Katowice, Polen, 40-519
        • Rekruttering
        • Novartis Investigative Site
      • Krakow, Polen, 30-688
        • Fullført
        • Novartis Investigative Site
      • Warsaw, Polen, 00-791
        • Rekruttering
        • Novartis Investigative Site
      • Wroclaw, Polen, 50-367
        • Fullført
        • Novartis Investigative Site
  • Portugal
      • Lisbon, Portugal, 1099-023
        • Aktiv, ikke rekrutterende
        • Novartis Investigative Site
      • Porto, Portugal, 4200-072
        • Rekruttering
        • Novartis Investigative Site
  • Romania
      • Timișoara, Romania, 300079
        • Fullført
        • Novartis Investigative Site
  • Russland
      • Moscow, Russland, 125284
        • Aktiv, ikke rekrutterende
        • Novartis Investigative Site
      • Moscow, Russland, 125167
        • Aktiv, ikke rekrutterende
        • Novartis Investigative Site
      • Saint Petersburg, Russland, 191024
        • Rekruttering
        • Novartis Investigative Site
      • Saint Petersburg, Russland, 197341
        • Rekruttering
        • Novartis Investigative Site
  • Saudi-Arabia
      • Riyadh, Saudi-Arabia, 11211
        • Fullført
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Aktiv, ikke rekrutterende
        • Novartis Investigative Site
  • Spania
      • Barcelona, Spania, 08035
        • Rekruttering
        • Novartis Investigative Site
      • Barcelona, Spania, 08036
        • Fullført
        • Novartis Investigative Site
      • Madrid, Spania, 28041
        • Fullført
        • Novartis Investigative Site
      • Madrid, Spania, 28006
        • Rekruttering
        • Novartis Investigative Site
      • Madrid, Spania, 28034
        • Fullført
        • Novartis Investigative Site
      • Seville, Spania, 41009
        • Rekruttering
        • Novartis Investigative Site
      • Valencia, Spania, 46026
        • Rekruttering
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spania, 15706
        • Rekruttering
        • Novartis Investigative Site
    • Barcelona
      • Badalona, Barcelona, Spania, 08916
        • Rekruttering
        • Novartis Investigative Site
      • L'Hospitalet de Llobregat, Barcelona, Spania, 08907
        • Fullført
        • Novartis Investigative Site
    • Bizkaia
      • Bilbao, Bizkaia, Spania, 48013
        • Rekruttering
        • Novartis Investigative Site
    • Santa Cruz De Tenerife
      • Santa Cruz, Santa Cruz De Tenerife, Spania, 38009
        • Rekruttering
        • Novartis Investigative Site
  • Storbritannia
      • London, Storbritannia, W12 0HS
        • Rekruttering
        • Novartis Investigative Site
      • Oxford, Storbritannia, OX3 7LE
        • Rekruttering
        • Novartis Investigative Site
  • Sør -Korea
      • Busan, Sør -Korea, 49201
        • Fullført
        • Novartis Investigative Site
      • Jeollanam, Sør -Korea, 519763
        • Fullført
        • Novartis Investigative Site
      • Seoul, Sør -Korea, 03080
        • Rekruttering
        • Novartis Investigative Site
    • Gyeonggi-do
      • Uijeongbu-si, Gyeonggi-do, Sør -Korea, 11759
        • Aktiv, ikke rekrutterende
        • Novartis Investigative Site
  • Taiwan
      • Taoyuan, Taiwan, 33305
        • Aktiv, ikke rekrutterende
        • Novartis Investigative Site
  • Tsjekkia
      • Brno, Tsjekkia, 625 00
        • Rekruttering
        • Novartis Investigative Site
    • Poruba
      • Ostrava, Poruba, Tsjekkia, 708 52
        • Rekruttering
        • Novartis Investigative Site
  • Tyrkia (Türkiye)
    • Atakum
      • Samsun, Atakum, Tyrkia (Türkiye), 55200
        • Rekruttering
        • Novartis Investigative Site
  • Tyskland
      • Berlin, Tyskland, 13353
        • Rekruttering
        • Novartis Investigative Site
      • Kiel, Tyskland, 24116
        • Rekruttering
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Tyskland, 60590
        • Rekruttering
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Tyskland, 07740
        • Rekruttering
        • Novartis Investigative Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Rekruttering
        • Novartis Investigative Site
      • Ho Chi Minh City, Vietnam, 70000
        • Rekruttering
        • Novartis Investigative Site
  • Østerrike
      • Graz, Østerrike, 8036
        • Rekruttering
        • Novartis Investigative Site
      • Vienna, Østerrike, 1140
        • Rekruttering
        • Novartis Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

7 år til 100 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: Asciminib single agent

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Andre navn:
  • ABL001
Annen: Bosutinib single agent group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib
Legemiddel: Bosutinib

Taken orally, once daily, with food
Eksperimentell: 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
Legemiddel: Asciminib single agent

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Andre navn:
  • ABL001
Eksperimentell: Asciminib in combination with imatinib group

Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
Legemiddel: Imatinib

Taken orally, once daily, in the morning with low-fat meal

Andre navn:
  • STI571
Eksperimentell: 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
Legemiddel: Nilotinib

Taken orally, twice daily, on an empty stomach

Andre navn:
  • AMN107
Annen: Imatinib single agent group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib
Legemiddel: Imatinib

Taken orally, once daily, in the morning with low-fat meal

Andre navn:
  • STI571
Annen: Nilotinib single agent group

Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib
Legemiddel: Nilotinib

Taken orally, twice daily, on an empty stomach

Andre navn:
  • AMN107
Eksperimentell: Asciminib in combination with dasatinib group

Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib
Legemiddel: Dasatinib

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Andre navn:
  • Sprycel
Annen: Dasatinib single agent group

Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
Legemiddel: Dasatinib

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Andre navn:
  • Sprycel
Eksperimentell: 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
Legemiddel: Asciminib single agent

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Andre navn:
  • ABL001
Eksperimentell: 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
Legemiddel: 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.

Andre navn:
  • ABL001

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of participants with clinical benefit as assessed by Investigator
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Etterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. august 2022

Primær fullføring (Antatt)

30. august 2030

Studiet fullført (Antatt)

30. august 2030

Datoer for studieregistrering

Først innsendt

4. mai 2021

Først innsendt som oppfylte QC-kriteriene

4. mai 2021

Først lagt ut (Faktiske)

7. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CABL001A2001B
  • 2021-000602-17 (EudraCT-nummer)
  • 2023-507557-16-00 (Annen identifikator: EU CTIS)
  • 2023 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-deling Støtteinformasjonstype

  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere