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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Novartis Pharmaceuticals

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. september 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CABL001J1AE01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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