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Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

5. august 2019 opdateret af: Gilead Sciences

A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

261

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Woodville, Australien, 5011
        • Queen Elizabeth Hospital
    • New South Wales
      • Kogarah, New South Wales, Australien, 2217
        • Saint George and Sutherland Hospitals
      • Randwick, New South Wales, Australien, 2031
        • Prince of Wales Hospital
      • Westmead, New South Wales, Australien, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australien, 4029
        • Royal Brisbane and Women's Hospital
      • Milton, Queensland, Australien, 4064
        • Haematology and Oncology Clinics of Australia at Mater
    • South Australia
      • Ashford, South Australia, Australien, 5035
        • Ashford Cancer Centre Research
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Box Hill Hospital
      • Melbourne, Victoria, Australien, 3199
        • Frankston Hospital
  • Belgien
      • Antwerpen, Belgien, 2060
        • Ziekenhuis Netwerk Antwerpen
      • Brussels, Belgien, 1200
        • Cliniques Universitaires Saint Luc
      • Ghent, Belgien, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgien, 3000
        • Universitaire Ziekenhuis Gasthuisberg
  • Canada
      • Winnipeg, Canada, R3E 0V9
        • Cancer Care Manitoba
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Cancer Care Manitoba
    • Ontario
      • Sudbury, Ontario, Canada, P3E 5J1
        • Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Centre Hospitalier Universitaire de Montréal
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre Hospitalier Regional De Rimouski
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
        • Saskatchewan Cancer Agency
  • Danmark
      • Aalborg, Danmark, 9100
        • Aalborg Hospital
      • Århus, Danmark, 8000
        • Aarhus University Hospital
  • Det Forenede Kongerige
      • Leeds, Det Forenede Kongerige, LS9 7TF
        • Saint James's University Hospital
      • London, Det Forenede Kongerige, WC1E 6BT
        • University College London
      • London, Det Forenede Kongerige, NW1 2PG
        • University College London
      • Oxford, Det Forenede Kongerige, OX3 7LE
        • Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)
    • England
      • Birmingham, England, Det Forenede Kongerige, B9 5ST
        • Birmingham Heartlands Hospital
      • Dartford, England, Det Forenede Kongerige, DA2 8DA
        • Darent Valley Hospital
      • Guildford, England, Det Forenede Kongerige, GU2 7XX
        • Royal Surrey County Hospital NHS Trust
      • Manchester, England, Det Forenede Kongerige, M20 4BX
        • Haematology and Transplant Unit
    • Norfolk
      • Norwich, Norfolk, Det Forenede Kongerige, NR4 7UY
        • Norfolk and Norwich University Hospital
  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • City of Hope
      • Fresno, California, Forenede Stater, 93720
        • California Cancer Associates for Research and Excellence (cCare)
      • San Diego, California, Forenede Stater, 92120
        • Kaiser Permanente
      • San Luis Obispo, California, Forenede Stater, 93401
        • Coastal Integrative Cancer Care
      • Stanford, California, Forenede Stater, 94305
        • Stanford University Medical Center
      • Vallejo, California, Forenede Stater, 94589
        • Kaiser Permanente Vallejo Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80205
        • Kaiser Permanente of Colorado
      • Grand Junction, Colorado, Forenede Stater, 81501
        • Saint Mary's Regional Cancer Center
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32256
        • Cancer Specialists of North Florida
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Georgia Regents University
    • Kentucky
      • Mount Sterling, Kentucky, Forenede Stater, 40353
        • Montgomery Cancer Center
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20817
        • Center for Cancer and Blood Disorders, PC
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110-1010
        • Washington University Medical Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, Forenede Stater, 10065
        • Weill Cornell Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Oncology Hematology Care, Inc.
      • Columbus, Ohio, Forenede Stater, 43202
        • The Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29601
        • Upstate Oncology Associates
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Forenede Stater, 37203-1781
        • Tenessee Oncology, PLLC
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists
    • Washington
      • Tacoma, Washington, Forenede Stater, 98405
        • Northwest Medical Specialties
  • Frankrig
      • Auvergne, Frankrig, 63000
        • CHRU Clermont- Ferrand CHU Estaing
      • Ile-de-france, Frankrig, 93009
        • Centre Hospitalier Universitaire Hopital Avicenne
    • Aquitaine
      • Pessac Cedex, Aquitaine, Frankrig, 33604
        • Center Hospitalier Universitaire de Bordeaux
    • Ile-de-france
      • Paris Cedex 10, Ile-de-france, Frankrig, 75010
        • Hopital Saint Louis
    • Languedoc-Roussillon
      • Perpignan, Languedoc-Roussillon, Frankrig, 66046
        • Centre Hospitalier de Perpignan
    • Limousin, Lorraine
      • Vandoeuvre, Limousin, Lorraine, Frankrig, 54511
        • Centre Hospitalier Universitaire Nancy
    • Midi-pyrenees
      • Toulouse Cedex, Midi-pyrenees, Frankrig, 31059
        • Centre Hospitalier Universitaire Purpan
  • Irland
      • Cork, Irland
        • University College Cork
      • Dublin, Irland, 8
        • Saint James's Hospital
  • Polen
      • Brzozow, Polen, 36-200
        • Szpital Specjalistyczny w Brzozowie
      • Lódz, Polen, 93-510
        • Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
      • Warszawa, Polen, 02-507
        • Centralny Szpital Kliniczny MSW
      • Wroclaw, Polen, 50-367
        • Samodzielny Publiczny Szpital Kliniczny N1 Klinika
    • Malopolskie
      • Kraków, Malopolskie, Polen, 31-501
        • Collegium Medicum Uniwersytetu Jagiellonskiego w K
    • Pomorskie
      • Slupsk, Pomorskie, Polen, 76-200
        • Wojewódzki Szpital Specjalistyczny im. Janusza Kor
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Vall d´hebron
      • Barcelona, Spanien, 08025
        • Hospital Clinic I Provincial
      • Madrid, Spanien, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spanien, 28041
        • Hospital Universitario 12 de octubre
      • Madrid, Spanien, 28222
        • Hospital Puerta de Hierro Majadahonda
      • Murcia, Spanien, 30008
        • Hospital Morales Meseguer
  • Sverige
      • Luleå, Sverige, 971 80
        • Sunderby Sjukhus
      • Stockholm, Sverige, 171 64
        • Karolinska University Hospital Solna
      • Stockholm, Sverige, 171 76
        • Karolinska University Hospital Huddinge

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

Key Inclusion Criteria:

  • Adults with previously treated recurrent CLL who have measurable lymphadenopathy
  • Require therapy for CLL
  • Have experienced CLL progression < 24 months since the completion of the last prior therapy
  • Have disease that is not refractory to ofatumumab

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Idelalisib+ofatumumab

Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Medicin: Idelalisib
150 mg tabletter indgivet oralt to gange dagligt
Andre navne:
  • Zydelig®
  • GS-1101
  • CAL-101
Medicin: Ofatumumab
Administered intravenously
Andre navne:
  • Arzerra®
Aktiv komparator: Ofatumumab

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Medicin: Ofatumumab
Administered intravenously
Andre navne:
  • Arzerra®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival
Tidsramme: Randomization to End of Study (up to 60 months)
Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.
Randomization to End of Study (up to 60 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate
Tidsramme: Randomization to End of Study (up to 60 months)

Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.

  • Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
  • Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. Overall response rate was analyzed using KM estimates.
Randomization to End of Study (up to 60 months)
Lymph Node Response Rate
Tidsramme: Randomization to End of Study (up to 60 months)
Lymph node response rate was defined as the proportion of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.
Randomization to End of Study (up to 60 months)
Overall Survival
Tidsramme: Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.
Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation
Tidsramme: Randomization to End of Study (up to 60 months)
Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.
Randomization to End of Study (up to 60 months)
Complete Response Rate
Tidsramme: Randomization to End of Study (up to 60 months)
Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).
Randomization to End of Study (up to 60 months)

Samarbejdspartnere og efterforskere

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

Sponsor

Gilead Sciences

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.

Generelle publikationer

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)

4. december 2012

Primær færdiggørelse (Faktiske)

15. august 2018

Studieafslutning (Faktiske)

15. august 2018

Datoer for studieregistrering

Først indsendt

3. august 2012

Først indsendt, der opfyldte QC-kriterier

3. august 2012

Først opslået (Skøn)

7. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GS-US-312-0119
  • 2012-001236-65 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

IPD-delingstidsramme

18 months after study completion

IPD-delingsadgangskriterier

A secured external environment with username, password, and RSA code.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

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 .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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