Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Efficacy of Asciminib in Real-world in Patients With Chronic Myeloid Leukemia in Second or Subsequent Lines (ASCIRLI)

8. juni 2026 opdateret af: Gruppo Italiano Malattie EMatologiche dell'Adulto

Retrospective and Prospective Observational Study on the Efficacy and Tolerability of Asciminib in Real-world Clinical Practice in Patients With Chronic Myeloid Leukemia Treated in Second or Subsequent Lines: ASCIRLI (ASCIminib in Real-Life Italy)

The goal of this observational study is to evaluate the efficacy and tolerability of asciminib in real-life in patients with chronic myeloid leukemia treated in second or subsequent lines. The main object of the study is to assess the achievement of Major Molecular Response.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

ASCIRLI is an observational, multicenter, retrospective and prospective study designed to include all adult patients with chronic-phase chronic myeloid leukemia (CML-CP) who initiated second-line or subsequent lines of therapy with asciminib after the date of its commercial availability. In detail, treatment with asciminib in third or greater line was approved in July 2023, while treatment in the other lines of therapy was approved in December 2025. Patients will be included according to these timelines. The study aims to generate comprehensive real-world evidence on the effectiveness, safety, tolerability, and health-related quality of life (HRQoL) associated with asciminib use in routine clinical practice, complementing data derived from controlled clinical trials and reflecting treatment patterns, patient characteristics, and outcomes observed in an unselected population. Treatment with asciminib will be independent from participation to this observational study and must not be initiated for the purpose of participating to this study.

Clinical data at the time of enrollment will be collected, together with previous history of resistance and/or intolerance to previous lines of treatment, including type of adverse events and mutations. Cytogenetic (eventually) and molecular responses will be collected at 3, 6,12 and subsequent follow-up according to ELN criteria.

Discontinuation and dose adjustments will be recorded. Patients will be followed according to the routine medical practice expected at least every 3-6 months.

The recruitment period is planned for 24 months from the first patient included, observation period for 36 months, with a total study duration of 60 months.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

98

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

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

The study will include all adult patients with chronic-phase chronic myeloid leukemia (CML-CP) who initiated second-line or subsequent lines of therapy with asciminib after the date of its commercial availability. In detail, treatment with asciminb in third or greater line was approved in July 2023, while treatment in the other lines of therapy was approved by EMA in December 2025. Patients will be included according to these timelines.

Beskrivelse

Inclusion Criteria:

  1. Patients aged ≥ 18 years and no upper age limit;
  2. Patients with a diagnosis of CML-CP who started treatment with asciminib according to clinical practice - from the date of commercial availability of asciminib - until the end of recruitment period (two years after the first patient included);
  3. Patients treated with asciminib in second or subsequent lines of therapy (≥2L)
  4. Patients who provide written informed consent to participate in the study (if applicable).

Exclusion Criteria:

  • None

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
Patients with chronic myeloid leukemia treated with asciminib in the real-life
Patients with chronic phase myeloid leukemia treated in second or subsequent lines with asciminib according to clinical practice

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of response to asciminib
Tidsramme: 24 months
Proportion of patients achieving Major Molecular Response (MMR) by RT-PCR at 24 months after the start of asciminib treatment
24 months

Samarbejdspartnere og efterforskere

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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Efterforskere

  • Ledende efterforsker: Massimo Breccia, Sapienza University, Rome

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)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2031

Studieafslutning (Anslået)

1. december 2031

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CML1826

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk myeloid leukæmi

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Hong Kong

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner