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A Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region (ASC4Young)

6. august 2026 oppdatert av: Novartis Pharmaceuticals

ASC4Young: Real-World Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region

The aim of this study is to evaluate the real-world effectiveness and safety of asciminib among young adults with chronic myeloid leukemia (CML) across the Gulf region. The data source for this study will consist of routinely collected clinical information documented within the electronic health records (EHR) of participating centers.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

80

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

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

CML patients who initiate asciminib between 01 May 2023 and 31 May 2026 in participating centers across the Gulf region.

Beskrivelse

Inclusion Criteria

  • Confirmed diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP)
  • Adult patients aged ≥ 18 years at the index date (or adult as defined by applicable national regulations)
  • Documented exposure to asciminib during the identification period (May 2023 to May 2026)
  • Provision of signed informed consent for secondary use of data, or an ethics committee-approved waiver of consent, where applicable (including for deceased patients or where data were previously collected within the EHR system)

Exclusion Criteria

  • Patients who do not meet the eligibility criteria specified above
  • Patients with insufficient medical record documentation to determine asciminib exposure or key study outcomes

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Young Adults Cohort
CML patients aged ≤ 40 years at the first documented asciminib administration.
Older Adults Cohort
CML patients aged > 40 years at the first documented asciminib administration.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Major Molecular Response (MMR) Rate in Young Adults
Tidsramme: Approximately 12 Months
MMR is defined as a BCR::ABL1 level on the International Scale (BCR::ABL1 IS) ≤ 0.1%.
Approximately 12 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Adverse Events (AEs)
Tidsramme: Approximately 3, 6, and 12 months
Approximately 3, 6, and 12 months
Number of Patients by Type and Severity of AEs
Tidsramme: Approximately 3, 6, and 12 months
Number of patients by type and severity of AEs including serious AEs and grade ≥ 3 AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Approximately 3, 6, and 12 months
Incidence of AEs Leading to Dose Modifications
Tidsramme: Approximately 3, 6, and 12 months
Dose modifications include treatment interruptions and dose reductions.
Approximately 3, 6, and 12 months
Number of Treatment Interruptions Due to AEs
Tidsramme: Approximately 3, 6, and 12 months
Approximately 3, 6, and 12 months
Duration of Treatment Interruptions Due to AEs
Tidsramme: Approximately 3, 6, and 12 months
Approximately 3, 6, and 12 months
Time to Treatment Discontinuation due to Adverse Events (TTDAE)
Tidsramme: Approximately 3, 6, and 12 months
Approximately 3, 6, and 12 months
Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 10% After 3 Months of Treatment
Tidsramme: 3 months
3 months
Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 1% After 6 Months of Treatment
Tidsramme: 6 months
6 months
MMR in Patients Aged > 40 years
Tidsramme: Approximately 12 months
MMR is defined as BCR::ABL1 IS ≤ 0.1%.
Approximately 12 months
Rate of Deep Molecular Response
Tidsramme: Approximately 12 months

Deep molecular response includes:

  • Molecular response (MR) 4.0 (BCR::ABL1 IS ≤ 0.01%), and
  • MR4.5 (BCR::ABL1 IS ≤ 0.0032%), where available.
Approximately 12 months
Number of Patients With Prior Tyrosine Kinase Inhibitor (TKI) Treatment
Tidsramme: Up to 12 months prior to Baseline
Up to 12 months prior to Baseline
Duration of CML at Time of Asciminib Treatment Initiation
Tidsramme: Baseline
Baseline
Asciminib Starting Dose
Tidsramme: Baseline
Baseline
Number of Patients With Dose Modifications
Tidsramme: Approximately 3, 6, and 12 months
Number of patients with dose modifications including up titration or dose reduction.
Approximately 3, 6, and 12 months
Number of Treatment Interruptions
Tidsramme: Approximately 3, 6, and 12 months
Approximately 3, 6, and 12 months
Duration of Treatment Interruptions
Tidsramme: Approximately 3, 6, and 12 months
Approximately 3, 6, and 12 months
Number of Patients by Reasons for Treatment Interruptions and Subsequent Treatment Switching
Tidsramme: Approximately 3, 6, and 12 months
Approximately 3, 6, and 12 months
Number of Patients by Reason for Treatment Switch
Tidsramme: Approximately 3, 6, and 12 months
Approximately 3, 6, and 12 months
Number of Patients by Clinicopathological Characteristics
Tidsramme: Up to 12 months pre-Baseline, Baseline, and approximately 3, 6 , and 12 months post-Baseline

Clinicopathological characteristics include:

  • Demographics (gender, ethnicity, nationality, smoking status, and insurance status)
  • Clinical presentation (signs and symptoms of disease)
  • Laboratory parameters (lipid panel, complete blood count, clinical chemistry, kidney, liver and pancreas function tests)
  • Molecular findings (BCR::ABL1 transcript types, additional cytogenetic abnormalities, and other reported mutations)
Up to 12 months pre-Baseline, Baseline, and approximately 3, 6 , and 12 months post-Baseline

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 (Antatt)

30. september 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

26. juni 2026

Først innsendt som oppfylte QC-kriteriene

26. juni 2026

Først lagt ut (Faktiske)

2. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CABL001J1AE01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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