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A Real-world Study of Asciminib Effectiveness in Philadelphia Positive Acute Lymphoblastic Leukemia Patients (ASCERTAIN)

maanantai 8. kesäkuuta 2026 päivittänyt: Novartis Pharmaceuticals

Asciminib Effectiveness in Real World Setting of Philadelphia Positive Acute Lymphoblastic Leukemia (Ph+ALL); a Retrospective Review Study of Patients From the Asciminib Managed Access Program (ASCERTAIN)

The aim of this study was to collect existing information from the medical charts of patients enrolled in the ongoing asciminib Managed Access Program (MAP) to better understand the effectiveness and safety of asciminib when used to treat adult patients with Ph+ ALL who are refractory, resistant or intolerant to available treatments.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

37

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Alankomaat
      • Rotterdam, Alankomaat, 3015
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Novartis Investigative Site
  • Espanja
      • Madrid, Espanja, 28006
        • Novartis Investigative Site
  • Israel
      • Ramat Gan, Israel, 52621
        • Novartis Investigative Site
  • Italia
      • Ascoli Piceno, Italia, 63100
        • Novartis Investigative Site
      • Bari, Italia, 70124
        • Novartis Investigative Site
      • Catania, Italia, 95123
        • Novartis Investigative Site
      • Cuneo, Italia, 12100
        • Novartis Investigative Site
      • Pescara, Italia, 65124
        • Novartis Investigative Site
      • Torino, Italia, 10126
        • Novartis Investigative Site
  • Kanada
      • Montreal, Kanada, H1T 2M4
        • Novartis Investigative Site
  • Kiina
      • Hong Kong, Kiina
        • Novartis Investigative Site
  • Pakistan
      • Islamabad, Pakistan, 44000
        • Novartis Investigative Site
      • Rawalpindi, Pakistan, 46000
        • Novartis Investigative Site
  • Puola
      • Bialystok, Puola, 15-276
        • Novartis Investigative Site
  • Ranska
      • Le Chesnay, Ranska, 78150
        • Novartis Investigative Site
  • Yhdistynyt kuningaskunta
      • London, Yhdistynyt kuningaskunta, SE5 9RS
        • Novartis Investigative Site
  • Yhdysvallat
    • Massachusetts
      • Boston, Massachusetts, Yhdysvallat, 02115
        • Novartis Investigative Site

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

Patients with Ph+ ALL who were enrolled in the asciminib MAP and received at least one dose of asciminib.

Kuvaus

Inclusion criteria

  • Adult patients enrolled in the asciminib MAP.
  • Diagnosis of Ph+ ALL.
  • Patients received at least one dose of asciminib through the asciminib MAP.

  • Appropriate approval obtained for the use of patient data including:

    • Signed informed consent form (ICF), or
    • ICF waiver granted by an Institutional review board/Independent Ethics Committee (IRB/IEC).

Exclusion criteria

• Age < 18 years at the time of initiating asciminib treatment.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Asciminib Cohort
Ph+ ALL patients who received at least one dose of asciminib through the asciminib MAP.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Proportion of Patients Achieving Hematological Complete Remission (CR) or Hematological Complete Remission With Incomplete Count Recovery (CRi) in the First 3 Months of Treatment
Aikaikkuna: 3 months

Hematological CR was defined as no circulating lymphoblasts, absolute neutrophil count (ANC) ≥1,000/μL, platelets ≥100K/μL.

Hematological CRi was defined as no circulating lymphoblasts, ANC ˂1,000/μL, platelets ˂100K/μL.
3 months

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Proportion of Patients With Minimal Residual Disease (MRD) Evaluated in Peripheral Blood at Best Response
Aikaikkuna: From Day 1 to 120, and at Baseline, Day 28, 60, 90, 180, 270, 360

MRD, defined as the percentage of leukemia cells remaining after treatment with asciminib with the use of flow cytometry, polymerase chain reaction (PCR), and/or next generation sequencing (NGS) techniques (flow or molecular based MRD is defined as non-detectable if less than 0.01%. NGS MRD is defined as non-detected if less than 1 in 1 x 10^6 cells).

Best response: CR or CRi achievement. CR was defined as no circulating lymphoblasts, ANC ≥1,000/μL, platelets ≥100K/μL. CRi was defined as no circulating lymphoblasts, ANC ˂1,000/μL, platelets ˂100K/μL.
From Day 1 to 120, and at Baseline, Day 28, 60, 90, 180, 270, 360
Proportion of Patients Who Showed MRD Positivity and MRD Negativity
Aikaikkuna: Baseline, Day 28, 60, 90, 180, 270, 360
MRD, defined as the percentage of leukemia cells remaining after treatment with asciminib with the use of flow cytometry, PCR, and/or NGS techniques (flow or molecular based MRD is defined as non-detectable if less than 0.01%. NGS MRD is defined as non-detected if less than 1 in 1 x 10^6 cells).
Baseline, Day 28, 60, 90, 180, 270, 360
Duration of Response (DoR)
Aikaikkuna: Up to 5 years and 4 months

DoR measured as the time from achievement of CR or CRi, whichever occurs first, to relapse or death due to acute lymphoblastic leukemia (ALL) at the time of data cut-off.

CR was defined as no circulating lymphoblasts, ANC ≥1,000/μL, platelets ≥100K/μL. CRi was defined as no circulating lymphoblasts, ANC ˂1,000/μL, platelets ˂100K/μL.
Up to 5 years and 4 months
Proportion of Patients in Hematological CR or CRi Within 13 Months From Start of Treatment
Aikaikkuna: By Day 28 ± 7 (Day 1 to Day 35), at Day 90 ± 30, by Day 90 ± 30 (Day 1 to Day 120), at Day 180 ± 30, by Day 180 ± 30 (Day 1 to Day 210), at Day 270 ± 30, by Day 270 ± 30 (Day 1 to Day 300), at Day 360 ± 30, by Day 360 ± 30 (Day 1 to Day 390)

Hematological CR was defined as no circulating lymphoblasts, ANC ≥1,000/μL, platelets ≥100K/μL.

Hematological CRi was defined as no circulating lymphoblasts, ANC ˂1,000/μL, platelets ˂100K/μL.
By Day 28 ± 7 (Day 1 to Day 35), at Day 90 ± 30, by Day 90 ± 30 (Day 1 to Day 120), at Day 180 ± 30, by Day 180 ± 30 (Day 1 to Day 210), at Day 270 ± 30, by Day 270 ± 30 (Day 1 to Day 300), at Day 360 ± 30, by Day 360 ± 30 (Day 1 to Day 390)
Proportion of Patients in Complete Remission
Aikaikkuna: Day 28 ± 7 (Day 1 to Day 35), at Day 90 ± 30, by Day 90 ± 30 (Day 1 to Day 120), at Day 180 ± 30, by Day 180 ± 30 (Day 1 to Day 210), at Day 270 ± 30, by Day 270 ± 30 (Day 1 to Day 300), at Day 360 ± 30, by Day 360 ± 30 (Day 1 to Day 390)

Proportion of patients in complete remission (as per peripheral blood and bone marrow, when both available).

Complete Remission was defined as:

  • No circulating lymphoblasts or extramedullary disease
  • No lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass, central nervous system (CNS) involvement.
  • Trilineage hematopoiesis (TLH) and <5% blasts.
  • ANC ≥1000/μL.
  • Platelets ≥100,000/μL.
Day 28 ± 7 (Day 1 to Day 35), at Day 90 ± 30, by Day 90 ± 30 (Day 1 to Day 120), at Day 180 ± 30, by Day 180 ± 30 (Day 1 to Day 210), at Day 270 ± 30, by Day 270 ± 30 (Day 1 to Day 300), at Day 360 ± 30, by Day 360 ± 30 (Day 1 to Day 390)
Proportion of Patients in Complete Remission With Incomplete Recovery
Aikaikkuna: Day 28 ± 7 (Day 1 to Day 35), at Day 90 ± 30, by Day 90 ± 30 (Day 1 to Day 120), at Day 180 ± 30, by Day 180 ± 30 (Day 1 to Day 210), at Day 270 ± 30, by Day 270 ± 30 (Day 1 to Day 300), at Day 360 ± 30, by Day 360 ± 30 (Day 1 to Day 390)

Proportion of patients in complete remission with incomplete recovery (as per peripheral blood and bone marrow, when both available). Complete remission with incomplete recovery was defined as meeting all criteria for complete remission except without recovery of platelet count or without recovery of ANC:

  • Platelets <100,000/μL and ANC ≥1000/μL or
  • Platelets ≥100,000/μL and ANC <1000/μL
Day 28 ± 7 (Day 1 to Day 35), at Day 90 ± 30, by Day 90 ± 30 (Day 1 to Day 120), at Day 180 ± 30, by Day 180 ± 30 (Day 1 to Day 210), at Day 270 ± 30, by Day 270 ± 30 (Day 1 to Day 300), at Day 360 ± 30, by Day 360 ± 30 (Day 1 to Day 390)
Proportion of Patients who Proceed to Stem Cell Transplantation (SCT)
Aikaikkuna: Up to 5 years and 4 months
Proportion of patients who proceed to SCT by the cutoff date.
Up to 5 years and 4 months
Proportion of Patients who Continued Treatment With Asciminib After Last SCT
Aikaikkuna: Up to 5 years and 4 months
Proportion of patients who proceed to SCT and continue treatment with asciminib by the cutoff date.
Up to 5 years and 4 months
Proportion of Patients With BCR::ABL1 T315I Mutation at Baseline and Correlation With Hematological CR/CRi With Asciminib Monotherapy or as a Combination by the Cutoff Date
Aikaikkuna: Up to 5 years and 4 months

Hematological CR was defined as no circulating lymphoblasts, ANC ≥1,000/μL, platelets ≥100K/μL.

Hematological CRi was defined as no circulating lymphoblasts, ANC ˂1,000/μL, platelets ˂100K/μL.
Up to 5 years and 4 months
Overall Survival (OS)
Aikaikkuna: Up to 5 years and 4 months
OS was defined as the time from start of treatment with asciminib to death due to any cause.
Up to 5 years and 4 months
Relapse-free Survival (RFS)
Aikaikkuna: Up to 5 years and 4 months

RFS was defined as the time from achievement of hematological CR or CRi, whichever occurs first, to relapse or death due to any cause.

Hematological CR was defined as no circulating lymphoblasts, ANC ≥1,000/μL, platelets ≥100K/μL.

Hematological CRi was defined as no circulating lymphoblasts, ANC ˂1,000/μL, platelets ˂100K/μL.
Up to 5 years and 4 months
Proportion of Patients Intolerant to Prior Therapy and not in Hematological CR or CRi at Baseline who Achieved CR or CRi as the Best Response
Aikaikkuna: During the first 3 months of treatment and at any time point until Day 360 ± 30

Hematological CR was defined as no circulating lymphoblasts, ANC ≥1,000/μL, platelets ≥100K/μL.

Hematological CRi was defined as no circulating lymphoblasts, ANC ˂1,000/μL, platelets ˂100K/μL.
During the first 3 months of treatment and at any time point until Day 360 ± 30
Among Patients Intolerant to Prior Therapy With MRD Negativity at Baseline, Duration of MRD
Aikaikkuna: Up to 5 years and 4 months
MRD, defined as the percentage of leukemia cells remaining after treatment with asciminib with the use of flow cytometry, PCR, and/or NGS techniques (flow or molecular based MRD is defined as non-detectable if less than 0.01%. NGS MRD is defined as non-detected if less than 1 in 1 x 10^6 cells)
Up to 5 years and 4 months
Proportion of Patients by Reasons for Starting Asciminib
Aikaikkuna: Up to 5 years and 4 months
Up to 5 years and 4 months
Proportion of Patients Who Achieved CR or CRi by Patient Characteristics
Aikaikkuna: Up to 5 years and 4 months
Patient characteristics included age group, gender, race and ethnicity, medical history, prior treatments, relapse/remission status, and treatment phase.
Up to 5 years and 4 months
Proportion of Patients by DoR and Patient Characteristics
Aikaikkuna: Up to 5 years and 4 months

DoR measured as the time from achievement of CR or CRi, whichever occurs first, to relapse or death due to ALL at the time of data cut-off. CR was defined as no circulating lymphoblasts, ANC ≥1,000/μL, platelets ≥100K/μL. CRi was defined as no circulating lymphoblasts, ANC ˂1,000/μL, platelets ˂100K/μL.

Patient characteristics included age group, gender, race and ethnicity, medical history, prior treatments, relapse/remission status, and treatment phase.
Up to 5 years and 4 months
Proportion of Patients With Adverse Events
Aikaikkuna: Up to 5 years and 4 months
Up to 5 years and 4 months

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Novartis Pharmaceuticals

Tutkijat

  • Opintojohtaja: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Opintoihin ilmoittautumispäivät

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Maanantai 8. kesäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 8. kesäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Perjantai 12. kesäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 12. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

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Viimeksi vahvistettu

Maanantai 1. kesäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CABL001A2007

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EI

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