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

5 agosto 2019 aggiornato da: 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).

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

261

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Belgio
      • Antwerpen, Belgio, 2060
        • Ziekenhuis Netwerk Antwerpen
      • Brussels, Belgio, 1200
        • Cliniques Universitaires Saint Luc
      • Ghent, Belgio, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgio, 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
  • Danimarca
      • Aalborg, Danimarca, 9100
        • Aalborg Hospital
      • Århus, Danimarca, 8000
        • Aarhus University Hospital
  • Francia
      • Auvergne, Francia, 63000
        • CHRU Clermont- Ferrand CHU Estaing
      • Ile-de-france, Francia, 93009
        • Centre Hospitalier Universitaire Hopital Avicenne
    • Aquitaine
      • Pessac Cedex, Aquitaine, Francia, 33604
        • Center Hospitalier Universitaire de Bordeaux
    • Ile-de-france
      • Paris Cedex 10, Ile-de-france, Francia, 75010
        • Hôpital Saint louis
    • Languedoc-Roussillon
      • Perpignan, Languedoc-Roussillon, Francia, 66046
        • Centre Hospitalier de Perpignan
    • Limousin, Lorraine
      • Vandoeuvre, Limousin, Lorraine, Francia, 54511
        • Centre Hospitalier Universitaire Nancy
    • Midi-pyrenees
      • Toulouse Cedex, Midi-pyrenees, Francia, 31059
        • Centre Hospitalier Universitaire Purpan
  • Irlanda
      • Cork, Irlanda
        • University College Cork
      • Dublin, Irlanda, 8
        • Saint James's Hospital
  • Polonia
      • Brzozow, Polonia, 36-200
        • Szpital Specjalistyczny w Brzozowie
      • Lódz, Polonia, 93-510
        • Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
      • Warszawa, Polonia, 02-507
        • Centralny Szpital Kliniczny MSW
      • Wroclaw, Polonia, 50-367
        • Samodzielny Publiczny Szpital Kliniczny N1 Klinika
    • Malopolskie
      • Kraków, Malopolskie, Polonia, 31-501
        • Collegium Medicum Uniwersytetu Jagiellonskiego w K
    • Pomorskie
      • Slupsk, Pomorskie, Polonia, 76-200
        • Wojewódzki Szpital Specjalistyczny im. Janusza Kor
  • Regno Unito
      • Leeds, Regno Unito, LS9 7TF
        • Saint James's University Hospital
      • London, Regno Unito, WC1E 6BT
        • University College London
      • London, Regno Unito, NW1 2PG
        • University College London
      • Oxford, Regno Unito, OX3 7LE
        • Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)
    • England
      • Birmingham, England, Regno Unito, B9 5ST
        • Birmingham Heartlands Hospital
      • Dartford, England, Regno Unito, DA2 8DA
        • Darent Valley Hospital
      • Guildford, England, Regno Unito, GU2 7XX
        • Royal Surrey County Hospital NHS Trust
      • Manchester, England, Regno Unito, M20 4BX
        • Haematology and Transplant Unit
    • Norfolk
      • Norwich, Norfolk, Regno Unito, NR4 7UY
        • Norfolk and Norwich University Hospital
  • Spagna
      • Barcelona, Spagna, 08035
        • Hospital Vall d´hebron
      • Barcelona, Spagna, 08025
        • Hospital Clinic I Provincial
      • Madrid, Spagna, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spagna, 28041
        • Hospital Universitario 12 de octubre
      • Madrid, Spagna, 28222
        • Hospital Puerta de Hierro Majadahonda
      • Murcia, Spagna, 30008
        • Hospital Morales Meseguer
  • Stati Uniti
    • California
      • Duarte, California, Stati Uniti, 91010
        • City of Hope
      • Fresno, California, Stati Uniti, 93720
        • California Cancer Associates for Research and Excellence (cCare)
      • San Diego, California, Stati Uniti, 92120
        • Kaiser Permanente
      • San Luis Obispo, California, Stati Uniti, 93401
        • Coastal Integrative Cancer Care
      • Stanford, California, Stati Uniti, 94305
        • Stanford University Medical Center
      • Vallejo, California, Stati Uniti, 94589
        • Kaiser Permanente Vallejo Medical Center
    • Colorado
      • Denver, Colorado, Stati Uniti, 80205
        • Kaiser Permanente of Colorado
      • Grand Junction, Colorado, Stati Uniti, 81501
        • Saint Mary's Regional Cancer Center
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32256
        • Cancer Specialists of North Florida
    • Georgia
      • Augusta, Georgia, Stati Uniti, 30912
        • Georgia Regents University
    • Kentucky
      • Mount Sterling, Kentucky, Stati Uniti, 40353
        • Montgomery Cancer Center
    • Maryland
      • Bethesda, Maryland, Stati Uniti, 20817
        • Center for Cancer and Blood Disorders, PC
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Dana Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63110-1010
        • Washington University Medical Center
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, Stati Uniti, 10065
        • Weill Cornell Medical Center
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45242
        • Oncology Hematology Care, Inc.
      • Columbus, Ohio, Stati Uniti, 43202
        • The Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Oregon Health and Science University
    • South Carolina
      • Greenville, South Carolina, Stati Uniti, 29601
        • Upstate Oncology Associates
    • Tennessee
      • Chattanooga, Tennessee, Stati Uniti, 37404
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Stati Uniti, 37203-1781
        • Tenessee Oncology, PLLC
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84106
        • Utah Cancer Specialists
    • Washington
      • Tacoma, Washington, Stati Uniti, 98405
        • Northwest Medical Specialties
  • Svezia
      • Luleå, Svezia, 971 80
        • Sunderby Sjukhus
      • Stockholm, Svezia, 171 64
        • Karolinska University Hospital Solna
      • Stockholm, Svezia, 171 76
        • Karolinska University Hospital Huddinge

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Idelalisib
Compresse da 150 mg somministrate per via orale due volte al giorno
Altri nomi:
  • Zydelig®
  • GS-1101
  • CAL-101
Droga: Ofatumumab
Administered intravenously
Altri nomi:
  • Arzerra®
Comparatore attivo: 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.
Droga: Ofatumumab
Administered intravenously
Altri nomi:
  • Arzerra®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-Free Survival
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Response Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gilead Sciences

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 dicembre 2012

Completamento primario (Effettivo)

15 agosto 2018

Completamento dello studio (Effettivo)

15 agosto 2018

Date di iscrizione allo studio

Primo inviato

3 agosto 2012

Primo inviato che soddisfa i criteri di controllo qualità

3 agosto 2012

Primo Inserito (Stima)

7 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

18 months after study completion

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Idelalisib

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Mozambique

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
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