Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

14. november 2019 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

54

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

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

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

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Lenalidomide
Open-label, oral lenalidomide monotherapy
Legemiddel: Lenalidomide
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
Andre navn:
  • Revlimid

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Celgene

Etterforskere

  • Studieleder: Kenichi Takeshita, MD, Celgene Corporation

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)

1. mars 2008

Primær fullføring (Faktiske)

1. mars 2010

Studiet fullført (Faktiske)

1. april 2010

Datoer for studieregistrering

Først innsendt

4. april 2008

Først innsendt som oppfylte QC-kriteriene

9. april 2008

Først lagt ut (Anslag)

10. april 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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