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Undersøgelse af Acalabrutinib alene eller i kombinationsterapi hos personer med B-celle non-Hodgkin lymfom

24. september 2026 opdateret af: Acerta Pharma BV

Et åbent, fase 1b/2-studie af Acalabrutinib alene eller i kombinationsterapi hos personer med B-celle non-Hodgkin-lymfom

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL.

Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR.

Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

113

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, t6G1Z2
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85719
        • Research Site
    • California
      • Downey, California, Forenede Stater, 90241
        • Research Site
      • Duarte, California, Forenede Stater, 91010
        • Research Site
      • Fountain Valley, California, Forenede Stater, 92708
        • Research Site
      • Santa Monica, California, Forenede Stater, 90404
        • Research Site
    • Florida
      • Coral Gables FL, Florida, Forenede Stater, 33146
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Research Site
      • Chicago, Illinois, Forenede Stater, 60637
        • Research Site
      • Chicago, Illinois, Forenede Stater, 60611
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40207
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Research Site
    • New Jersey
      • Morristown, New Jersey, Forenede Stater, 07960
        • Research Site
    • New York
      • Lake Success, New York, Forenede Stater, 11042
        • Research Site
      • New York, New York, Forenede Stater, 10021
        • Research Site
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • Research Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Research Site
      • Houston, Texas, Forenede Stater, 77030
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78217
        • Research Site
      • Temple, Texas, Forenede Stater, 76508
        • Research Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Research Site
    • Washington
      • Spokane, Washington, Forenede Stater, 99208
        • Research Site
  • Italien
      • Bologna, Italien, 40138
        • Research Site
      • Milan, Italien, 20132
        • Research Site
      • Palermo, Italien, 90146
        • Research Site

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • Part 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL, or subjects who have not previously received systemic anticancer therapy for FL., and which requires treatment.
  • Part 2: For subject with relapsed or refractory MZL:

Histologically confirmed MZL including splenic, nodal, and extranodal sub-types

  1. Subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4;

  2. Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma must be Helicobacter pylori (HP)-negative

    • Part 3: For subjects with FL: Pathologically confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL and which requires treatment per National Cancer Institute or ESMO clinical practice guidelines.
    • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
    • Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria:

  • •A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or Qtc >480 msec
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Breast feeding or pregnant

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part 1: acalabrutinib Regimen 1

acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects
Medicin: acalabrutinib
Andre navne:
  • ACP-196
Eksperimentel: Part 1: acalabrutinib Regimen 2

acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
Medicin: acalabrutinib
Andre navne:
  • ACP-196
Medicin: rituximab (IV)
Eksperimentel: Part 2: acalabrutinib Regimen 1

acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
Medicin: acalabrutinib
Andre navne:
  • ACP-196
Eksperimentel: Part 2: acalabrutinib Regimen 2

acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
Medicin: acalabrutinib
Andre navne:
  • ACP-196
Medicin: rituximab (IV)
Eksperimentel: Part 3: acalabrutinib Regimen 1

acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
Medicin: Lenalidomid
Medicin: acalabrutinib
Andre navne:
  • ACP-196
Medicin: rituximab (IV)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part 1: Incidence of Treatment-emergent Adverse Events.
Tidsramme: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).

Treatment-emergent adverse events were used to characterize the safety profile of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory follicular lymphoma (R/R FL).
From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).
Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
Tidsramme: Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).

The objective response rate (ORR) is used to characterize the activity of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).
Part 3: Incidence of Treatment-emergent Adverse Events.
Tidsramme: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).

Treatment-emergent adverse events were used to characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in participants with relapsed/refractory follicular lymphoma (R/R FL).
From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).

Samarbejdspartnere og efterforskere

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

Sponsor

Acerta Pharma BV

Samarbejdspartnere

AstraZeneca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 (Faktiske)

29. december 2014

Primær færdiggørelse (Faktiske)

25. august 2023

Studieafslutning (Anslået)

11. december 2028

Datoer for studieregistrering

Først indsendt

30. juni 2014

Først indsendt, der opfyldte QC-kriterier

1. juli 2014

Først opslået (Anslået)

3. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACE-LY-003
  • 2023-509350-63-00 (Registry Identifier: CTIS (EU))
  • 2019-000111-84 (EudraCT nummer)
  • 2023 (U.S. NIH-bevilling/kontrakt)
  • 2019 (U.S. NIH-bevilling/kontrakt)

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 .

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