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

5. august 2019 oppdatert av: 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).

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

261

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
      • Woodville, Australia, 5011
        • Queen Elizabeth Hospital
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Saint George and Sutherland Hospitals
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Milton, Queensland, Australia, 4064
        • Haematology and Oncology Clinics of Australia at Mater
    • South Australia
      • Ashford, South Australia, Australia, 5035
        • Ashford Cancer Centre Research
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Melbourne, Victoria, Australia, 3199
        • Frankston Hospital
  • Belgia
      • Antwerpen, Belgia, 2060
        • Ziekenhuis Netwerk Antwerpen
      • Brussels, Belgia, 1200
        • Cliniques Universitaires Saint Luc
      • Ghent, Belgia, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgia, 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
  • Forente stater
    • California
      • Duarte, California, Forente stater, 91010
        • City of Hope
      • Fresno, California, Forente stater, 93720
        • California Cancer Associates for Research and Excellence (cCare)
      • San Diego, California, Forente stater, 92120
        • Kaiser Permanente
      • San Luis Obispo, California, Forente stater, 93401
        • Coastal Integrative Cancer Care
      • Stanford, California, Forente stater, 94305
        • Stanford University Medical Center
      • Vallejo, California, Forente stater, 94589
        • Kaiser Permanente Vallejo Medical Center
    • Colorado
      • Denver, Colorado, Forente stater, 80205
        • Kaiser Permanente of Colorado
      • Grand Junction, Colorado, Forente stater, 81501
        • Saint Mary's Regional Cancer Center
    • Florida
      • Jacksonville, Florida, Forente stater, 32256
        • Cancer Specialists of North Florida
    • Georgia
      • Augusta, Georgia, Forente stater, 30912
        • Georgia Regents University
    • Kentucky
      • Mount Sterling, Kentucky, Forente stater, 40353
        • Montgomery Cancer Center
    • Maryland
      • Bethesda, Maryland, Forente stater, 20817
        • Center for Cancer and Blood Disorders, PC
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Dana Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110-1010
        • Washington University Medical Center
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, Forente stater, 10065
        • Weill Cornell Medical Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45242
        • Oncology Hematology Care, Inc.
      • Columbus, Ohio, Forente stater, 43202
        • The Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Oregon Health and Science University
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29601
        • Upstate Oncology Associates
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37404
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Forente stater, 37203-1781
        • Tenessee Oncology, PLLC
    • Utah
      • Salt Lake City, Utah, Forente stater, 84106
        • Utah Cancer Specialists
    • Washington
      • Tacoma, Washington, Forente stater, 98405
        • Northwest Medical Specialties
  • Frankrike
      • Auvergne, Frankrike, 63000
        • CHRU Clermont- Ferrand CHU Estaing
      • Ile-de-france, Frankrike, 93009
        • Centre Hospitalier Universitaire Hopital Avicenne
    • Aquitaine
      • Pessac Cedex, Aquitaine, Frankrike, 33604
        • Center Hospitalier Universitaire de Bordeaux
    • Ile-de-france
      • Paris Cedex 10, Ile-de-france, Frankrike, 75010
        • Hopital Saint Louis
    • Languedoc-Roussillon
      • Perpignan, Languedoc-Roussillon, Frankrike, 66046
        • Centre Hospitalier de Perpignan
    • Limousin, Lorraine
      • Vandoeuvre, Limousin, Lorraine, Frankrike, 54511
        • Centre Hospitalier universitaire Nancy
    • Midi-pyrenees
      • Toulouse Cedex, Midi-pyrenees, Frankrike, 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
  • Spania
      • Barcelona, Spania, 08035
        • Hospital Vall D´Hebron
      • Barcelona, Spania, 08025
        • Hospital Clinic I Provincial
      • Madrid, Spania, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spania, 28222
        • Hospital Puerta de Hierro Majadahonda
      • Murcia, Spania, 30008
        • Hospital Morales Meseguer
  • Storbritannia
      • Leeds, Storbritannia, LS9 7TF
        • Saint James's University Hospital
      • London, Storbritannia, WC1E 6BT
        • University College London
      • London, Storbritannia, NW1 2PG
        • University College London
      • Oxford, Storbritannia, OX3 7LE
        • Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)
    • England
      • Birmingham, England, Storbritannia, B9 5ST
        • Birmingham Heartlands Hospital
      • Dartford, England, Storbritannia, DA2 8DA
        • Darent Valley Hospital
      • Guildford, England, Storbritannia, GU2 7XX
        • Royal Surrey County Hospital NHS Trust
      • Manchester, England, Storbritannia, M20 4BX
        • Haematology and Transplant Unit
    • Norfolk
      • Norwich, Norfolk, Storbritannia, NR4 7UY
        • Norfolk and Norwich University Hospital
  • Sverige
      • Luleå, Sverige, 971 80
        • Sunderby Sjukhus
      • Stockholm, Sverige, 171 64
        • Karolinska University Hospital Solna
      • Stockholm, Sverige, 171 76
        • Karolinska University Hospital Huddinge

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Idelalisib
150 mg tabletter administrert oralt to ganger daglig
Andre navn:
  • Zydelig®
  • GS-1101
  • CAL-101
Legemiddel: Ofatumumab
Administered intravenously
Andre navn:
  • 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.
Legemiddel: Ofatumumab
Administered intravenously
Andre navn:
  • Arzerra®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gilead Sciences

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. desember 2012

Primær fullføring (Faktiske)

15. august 2018

Studiet fullført (Faktiske)

15. august 2018

Datoer for studieregistrering

Først innsendt

3. august 2012

Først innsendt som oppfylte QC-kriteriene

3. august 2012

Først lagt ut (Anslag)

7. august 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere