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A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma (EXPECT)

14. november 2019 opdateret af: Celgene

A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.

Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop.

All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase.

Objectives:

Primary:

• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.

Secondary:

• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study was terminated. Study data assessment revealed that study drug is active, but is not likely to be sufficiently active as a single agent in this population for registration purposes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

54

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australien, 2605
        • The Canberra Hospital Building 3, L 2
    • New South Wales
      • Liverpool, New South Wales, Australien, 2170
        • Cancer Therapy Centre
    • Queensland
      • Cairns, Queensland, Australien, 4870
        • Clinical Research Unit Cairns Base Hospital
      • Douglas, Queensland, Australien, 4814
        • The Townsville Hospital
      • Herston, Queensland, Australien, 4029
        • Royal Brisbane & Women's Hospital
    • South Australia
      • Ashford, South Australia, Australien, 5035
        • Ashford Cancer Centre
      • North Terrace, South Australia, Australien, 5000
        • Royal Adelaide Hospital L3 East Wing
    • Tasmania
      • Hobart, Tasmania, Australien, 7000
        • Royal Hobart Hospital
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Box Hill Hospital, 4th Floor, Clive Ward Centre
      • Clayton, Victoria, Australien, 3168
        • Monash Medical Centre
      • East Melbourne, Victoria, Australien, 3002
        • Peter MacCallum Cancer Centre
      • Fitzroy, Victoria, Australien, 3065
        • St Vincents Hospital
    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
        • Sir Charles Gairdner Hospital
  • Belgien
      • Bruxelles, Belgien, 1200
        • Cliniques Universitaires St Luc
      • Bruxelles, Belgien, 1000
        • Institute Jules Bordet
      • Leuven, Belgien, 3000
        • KUL
      • Ottignies, Belgien, 1340
        • Clinique St Pierre
      • Yvoir, Belgien, 5530
        • Cliniques Universitaires UCL de Mont-Godinne
  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater, 90211-1850
        • Tower Cancer Research Foundation
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Western Pennsylvania Hospital
  • Frankrig
      • Bordeaux, Frankrig, 33000
        • Polyclinique Bordeaux Nord Aquitaine
      • Clermont-Ferrand, Frankrig, 63000
        • Hôtel Dieu Pavillon Villemur Pasteur
      • Creteil, Frankrig, 94010
        • Hôpital Henri Mondor
      • Dijon, Frankrig, 21000
        • CHU de DIJON
      • Grenoble, Frankrig, 38043
        • Hopital Michallon
      • La Roche Sur Yon, Frankrig, 85000
        • CHD Les Oudairies
      • Limoges, Frankrig, 87042
        • CHU Dupuytren
      • Metz, Frankrig, 57000
        • Hôpital N.D.de Bon Secours
      • Paris, Frankrig, 75010
        • Hôpital Saint-Louis
      • Paris, Frankrig, 75015
        • Hôpital Necker
      • Paris, Frankrig, 75651
        • Hopital de la Pitie Salpetriere
      • Rennes, Frankrig, 35033
        • Chu Rennes Hopital Pontchaillou
      • Rouen, Frankrig, 76038
        • Centre Henri Becquerel
      • Saint Cloud, Frankrig, 92210
        • Centre Rene Huguenin
      • Toulouse, Frankrig, 31059
        • Hopital Purpan
      • Valence, Frankrig, 26953
        • Centre Hospitalier
    • Cedex 01
      • Nantes, Cedex 01, Frankrig, 44093
        • Chu Hotel Dieu
    • Cédex 1
      • Tours, Cédex 1, Frankrig, 37044
        • Hopital Bretonneau
    • Cédex 9
      • Angers, Cédex 9, Frankrig, 49033
        • CHU Hôpital Hôtel Dieu
    • Lille
      • Place De Verdun Cedex, Lille, Frankrig, 59037
        • Hopital Claude Huriez
    • Montpellier
      • Cedex, Montpellier, Frankrig, 34295
        • Hopital Lapeyronie
    • Pierre-Bénite
      • Lyon Sud, Pierre-Bénite, Frankrig, 69495
        • Centre Hospitalier Lyon Sud
    • Rue Morvan Cedex
      • Vandoeuvre Les Nancy, Rue Morvan Cedex, Frankrig, 54511
        • CHRU Hôpitaux de Brabois - Hématologie

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:

  • Must understand and voluntarily sign an informed consent form.
  • Must be ≥ 18 years of age at the time of signing the informed consent form.
  • Must be able to adhere to the study visit schedule and other protocol requirements.

  • Biopsy-proven T-cell Non-Hodgkin's Lymphoma, either:

    • Peripheral T-cell Lymphoma (PTCL) whatever the subtype, or
    • Cutaneous T-cell Lymphoma (CTCL), but only the subtype mycosis fungoides.
  • Relapsed or refractory to previous therapy for T-cell Non-Hodgkin's Lymphoma.
  • Must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies.

Exclusion Criteria:

  • Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.

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: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lenalidomide
Open-label, oral lenalidomide monotherapy
Medicin: Lenalidomide
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
Andre navne:
  • Revlimid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participants Categorized by Best Response as Determined by Investigator
Tidsramme: Up to 24 months

Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail):

  • Complete Response(CR): Complete disappearance of all detectable disease
  • Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow
  • Partial Response(PR): >50% decrease in six largest nodes/nodal masses
  • Stable Disease(SD): Less than PR, but not progressive disease
  • Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites
  • Progressive Disease(PD): >=50% increase from low in PR/Non-Responders
Up to 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of Response
Tidsramme: Up to 24 months
Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.
Up to 24 months
Time-to-Progression
Tidsramme: Up to 24 months
Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.
Up to 24 months
Progression-Free Survival
Tidsramme: Up to 24 months
Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.
Up to 24 months
Safety
Tidsramme: Up to 24 months
Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)
Up to 24 months

Samarbejdspartnere og efterforskere

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

Sponsor

Celgene

Efterforskere

  • Studieleder: Kenichi Takeshita, MD, Celgene Corporation

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)

1. marts 2008

Primær færdiggørelse (Faktiske)

1. marts 2010

Studieafslutning (Faktiske)

1. april 2010

Datoer for studieregistrering

Først indsendt

4. april 2008

Først indsendt, der opfyldte QC-kriterier

9. april 2008

Først opslået (Skøn)

10. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CC-5013-TCL-001
  • 2007-002171-13 (EudraCT nummer)

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 .

Kliniske forsøg med T-celle non-Hodgkins lymfom

Kliniske forsøg med Lenalidomide

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Kingdom

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner