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PRELUDIO:Estudio para investigar la prevención de la recaída en el linfoma usando enzastaurina diaria

6 de septiembre de 2018 actualizado por: Eli Lilly and Company

Un estudio clínico de fase 3 para investigar la prevención de la recaída en el linfoma usando enzastaurina diaria

Este estudio de investigación clínica es para investigar la prevención de la recaída en pacientes con linfoma difuso de células B grandes (DLBCL) que usan enzastaurina diariamente.

Este es un ensayo aleatorizado que compara Enzastaurin con Placebo (tratamiento ficticio), la posibilidad de recibir Enzastaurin es de 2 a 1.

Descripción general del estudio

Estado

Terminado

Condiciones

No linfoma de Hodgkin

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

758

Fase

Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Alemania
- - Berlin, Alemania, 13353
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Chemnitz, Alemania, 09113
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  - Erlangen, Alemania, 91054
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  - Frankfurt, Alemania, D-65929
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  - Giessen, Alemania, 35392
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  - Hamburg, Alemania, 20099
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  - Homburg, Alemania, 66421
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  - Kassel, Alemania, 34125
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  - Mainz, Alemania, 55131
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  - Muenchen, Alemania, 81675
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Australia
- Australian Capital Territory
  - Garran, Australian Capital Territory, Australia, 2605
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- New South Wales
  - Gosford, New South Wales, Australia, 2250
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- Northern Territory
  - Casuarina, Northern Territory, Australia, 0811
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- Queensland
  - Woolloongabba, Queensland, Australia, 4102
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Victoria
  - Heidelberg, Victoria, Australia, 3084
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Prahran, Victoria, Australia, 3181
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- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brasil
- - Belo Horizonte, Brasil, 30380-490
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Campinas, Brasil, 13083970
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  - Goiania, Brasil, 74075040
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  - Rio De Janeiro, Brasil, 22260020
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  - São Paulo, Brasil, 01223001
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Bélgica
- - Brugge, Bélgica, 8000
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Brussels, Bélgica, 1000
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Gent, Bélgica, 9000
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  - Leuven, Bélgica, 3000
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Roeselare, Bélgica, 8800
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Canadá
- Alberta
  - Edmonton, Alberta, Canadá, T6G 1Z2
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- British Columbia
  - Vancouver, British Columbia, Canadá, V5Z 4E6
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Ontario
  - Hamilton, Ontario, Canadá, L8V 5C2
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Toronto, Ontario, Canadá, M5G 2M9
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Quebec
  - Montreal, Quebec, Canadá, H3T 1E2
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Saskatchewan
  - Regina, Saskatchewan, Canadá, S4T 7T1
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chequia
- - Brno, Chequia, 62500
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Olomouc, Chequia, 775 20
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  - Prague, Chequia, 128 08
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Corea, república de
- - Daegu, Corea, república de, 700-721
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Goyang-Si, Corea, república de, 411-764
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  - Hwasun-Gun, Corea, república de, 519-809
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  - Seoul, Corea, república de, 138-736
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Dinamarca
- - Herlev, Dinamarca, 2730
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Odense, Dinamarca, 5000
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
España
- - Hospitalet Llobregat, España, 08907
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Madrid, España, 28041
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  - Oviedo, España, 33006
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Salamanca, España, 37007
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  - Santander, España, 39008
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Toledo, España, 45004
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  - Valencia, España, 46009
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  - Zaragoza, España, 50009
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Estados Unidos
- Alaska
  - Anchorage, Alaska, Estados Unidos, 99508
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- California
  - Los Angeles, California, Estados Unidos, 90095
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Florida
  - Orlando, Florida, Estados Unidos, 32806
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Illinois
  - Chicago, Illinois, Estados Unidos, 60637
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Indiana
  - Bloomington, Indiana, Estados Unidos, 47402
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Indianapolis, Indiana, Estados Unidos, 46202
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Iowa
  - Iowa City, Iowa, Estados Unidos, 52242
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Kentucky
  - Lexington, Kentucky, Estados Unidos, 40536
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Massachusetts
  - Boston, Massachusetts, Estados Unidos, 02115
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Minnesota
  - Robbinsdale, Minnesota, Estados Unidos, 55422
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Rochester, Minnesota, Estados Unidos, 55905
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Missouri
  - Columbia, Missouri, Estados Unidos, 65201
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Saint Louis, Missouri, Estados Unidos, 63131
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- North Carolina
  - Durham, North Carolina, Estados Unidos, 27710
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Oklahoma
  - Tulsa, Oklahoma, Estados Unidos, 74136
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Pennsylvania
  - Pittsburgh, Pennsylvania, Estados Unidos, 15232
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Tennessee
  - Memphis, Tennessee, Estados Unidos, 38138
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Texas
  - Houston, Texas, Estados Unidos, 77030
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - The Woodlands, Texas, Estados Unidos, 77380
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Utah
  - Salt Lake City, Utah, Estados Unidos, 84103
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Washington
  - Everett, Washington, Estados Unidos, 98201
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Seattle, Washington, Estados Unidos, 98104
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Vancouver, Washington, Estados Unidos, 98686
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Wisconsin
  - Madison, Wisconsin, Estados Unidos, 53792
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Finlandia
- - Helsinki, Finlandia, 00290
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Francia
- - Avignon, Francia, 84902
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Bayonne, Francia, 64109
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - La Roche Sur Yon, Francia, 85925
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Le Mans, Francia, 72000
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Nantes, Francia, 44202
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Nice, Francia, 06202
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Nimes, Francia, 30029
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Pessac, Francia, 33604
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Rennes, Francia, 35033
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Vandoeuvre Les Nancy, Francia, 54511
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Grecia
- - Athens, Grecia, 11527
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Haidari/Athens, Grecia, 12462
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Thessaloniki, Grecia, 54007
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hungría
- - Budapest, Hungría, 1122
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Miskolc, Hungría, 3529
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
India
- - Mumbai, India, 400 026
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  - New Delhi, India, 110017
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  - Pune, India, 411004
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  - Secunderabad, India, 500003
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  - Trivandrum, India, 695 011
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Italia
- - Aviano, Italia, 33081
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  - Bergamo, Italia, 24128
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  - Bologna, Italia, 40138
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  - Milano, Italia, 20162
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  - Pisa, Italia, 56100
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  - Reggio Emilia, Italia, 42100
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  - Rome, Italia, 00161
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  - Vicenza, Italia, 36100
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Japón
- - Aichi, Japón, 460-0001
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  - Fukuoka, Japón, 811-1395
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  - Gunma, Japón, 371-8511
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  - Kanagawa, Japón, 259-1193
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  - Kyoto, Japón, 602-8566
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  - Mie, Japón, 514-8507
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  - Miyagi, Japón, 980-8574
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  - Nagasaki, Japón, 852-8501
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  - Okayama, Japón, 710-8602
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  - Shiga, Japón, 524-8524
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  - Tokyo, Japón, 141
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México
- - Col. Florida, México, 01030
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  - Guadalajara, México, 44280
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  - Mexico City, México, 01120
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  - Monterrey, México, 64710
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  - San Luis Potosi, México, 78216
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  - Toluca, México, 50180
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Polonia
- - Lublin, Polonia, 20-090
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  - Olsztyn, Polonia, 10-228
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  - Poznan, Polonia, 60-569
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  - Warsaw, Polonia, 02-781
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  - Wroclaw, Polonia, 50-367
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Porcelana
- - Beijing, Porcelana, 100083
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  - Chengdu, Porcelana, 610041
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  - Guang Zhou, Porcelana, 510080
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  - Hangzhou, Porcelana, 310003
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  - Nanjing, Porcelana, 210029
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  - Shanghai, Porcelana, 200032
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  - Suzhou, Porcelana, 215006
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Portugal
- - Coimbra, Portugal, 3000-075
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  - Lisbon, Portugal, 1649-035
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  - Santa Maria Da Feira, Portugal, 4520-211
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Puerto Rico
- - San Juan, Puerto Rico, 00918
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Reino Unido
- - London, Reino Unido, SE1 9RT
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- Devon
  - Plymouth, Devon, Reino Unido, PL6 8DH
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- East Sussex
  - Brighton, East Sussex, Reino Unido, BN2 5BE
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- Kent
  - Maidstone, Kent, Reino Unido, ME16 9QQ
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- Scotland
  - Aberdeen, Scotland, Reino Unido, AB25 2ZN
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  - Glasgow, Scotland, Reino Unido, G12 0YN
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Suecia
- - Lund, Suecia, 221 85
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  - Umea, Suecia, 901 85
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  - Uppsala, Suecia, 75185
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Taiwán
- - Changhua, Taiwán, 500
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  - Chiayi City, Taiwán, 600
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  - Kaohsiung, Taiwán, 807
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  - Liouying/Tainan, Taiwán, 736
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  - Neihu Taipei, Taiwán, 114
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  - Taichung, Taiwán, 404
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  - Tainan, Taiwán, 70403
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  - Taipei, Taiwán, 220
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Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Criterios de inclusión:

Diagnóstico clínico de linfoma difuso de células B grandes
Terapia R-CHOP recientemente completada y remisión lograda
Puntuación del Índice Pronóstico Internacional (IPI) 3,4,5
Al menos 18 años de edad
Aceptar programa de seguimiento del estudio

Criterio de exclusión:

Han recibido terapia distinta a R-CHOP para el linfoma
Condición médica grave como infección, segundo cáncer, enfermedad cardíaca
Recibió radiación a más de una lesión
Incapaz de tragar tabletas

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Prevención
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Cuadruplicar

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Experimental: A	Droga: enzastaurina Dosis de carga de 1125 mg, luego 500 mg, oral, diarios, hasta la progresión de la enfermedad o un máximo de 3 años Otros nombres: LY317615
Comparador de placebos: B	Droga: placebo oral, diario

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Supervivencia general libre de enfermedad Periodo de tiempo: Línea de base para enfermedad progresiva medida o muerte por cualquier causa (hasta 80,30 meses)	El tiempo de supervivencia libre de enfermedad (DFS) general se define como el tiempo desde la fecha de inscripción en el estudio hasta la primera fecha de recurrencia de la enfermedad determinada objetivamente (enfermedad progresiva) o muerte por cualquier causa. La DFS se evaluó de acuerdo con las recomendaciones del Grupo de Trabajo Internacional. La enfermedad progresiva (PD) se define como un aumento de ≥ 50 % desde el punto más bajo en la suma del producto de los diámetros (SPD) de cualquier ganglio anormal previamente identificado para respondedores parciales o no respondedores, o la aparición de cualquier lesión nueva durante o en el final de la terapia.	Línea de base para enfermedad progresiva medida o muerte por cualquier causa (hasta 80,30 meses)

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Supervivencia libre de enfermedad a los 2 años Periodo de tiempo: Línea de base a 2 años	La supervivencia sin enfermedad a los 2 años (DFS2) se define como la tasa de SLE a los 2 años a partir de la fecha de inscripción en el estudio y se determina mediante la distribución de los tiempos de SLE generales. Las tasas de supervivencia libre de enfermedad a los 2 años se estimarán mediante el método de Kaplan-Meier.	Línea de base a 2 años
Supervivencia sin eventos Periodo de tiempo: Línea de base a DP objetivo, inicio de nueva terapia o muerte por cualquier causa (hasta 76,81 meses)	El tiempo general de supervivencia libre de eventos (EFS, por sus siglas en inglés) se define como el tiempo desde la fecha de inscripción en el estudio hasta la primera fecha de recurrencia de la enfermedad determinada objetivamente (enfermedad progresiva), institución de un nuevo tratamiento contra el cáncer o muerte por cualquier causa. La enfermedad progresiva (PD) se define como un aumento de ≥ 50 % desde el punto más bajo en la suma del producto de los diámetros (SPD) de cualquier ganglio anormal previamente identificado para respondedores parciales o no respondedores, o la aparición de cualquier lesión nueva durante o en el final de la terapia.	Línea de base a DP objetivo, inicio de nueva terapia o muerte por cualquier causa (hasta 76,81 meses)
Supervivencia libre de eventos a los 2 años Periodo de tiempo: Línea de base a 2 años	La supervivencia libre de eventos a los 2 años (EFS2) se define como la tasa de EFS a los 2 años a partir de la fecha de inscripción en el estudio y se determina mediante la distribución de tiempos de EFS generales. Las tasas de supervivencia libre de eventos a los 2 años se estimarán mediante el método de Kaplan-Meier.	Línea de base a 2 años
Sobrevivencia promedio Periodo de tiempo: Línea de base hasta la fecha de la muerte por cualquier causa (hasta 80,30 meses)	El tiempo de supervivencia general (SG) se define como el tiempo desde la fecha de inscripción en el estudio hasta la fecha de la muerte por cualquier causa.	Línea de base hasta la fecha de la muerte por cualquier causa (hasta 80,30 meses)
Número de participantes con eventos adversos emergentes del tratamiento Periodo de tiempo: Primera dosis hasta 30 días posteriores a la interrupción del tratamiento del estudio (hasta 81,30 meses)	Número de participantes con eventos adversos emergentes del tratamiento.	Primera dosis hasta 30 días posteriores a la interrupción del tratamiento del estudio (hasta 81,30 meses)
Calidad de vida: cambio desde el inicio en la evaluación funcional de la terapia del cáncer - Puntuación de linfoma (FACT-Lym) Periodo de tiempo: Línea de base, mes 2; línea de base, mes 4; línea de base, mes 6; línea de base, mes 12; línea de base, mes 18; línea de base, mes 24; Línea de base, mes 36	El FACT-Lym evalúa la calidad de vida relacionada con la salud (HRQoL) en participantes con linfoma no Hodgkin. Incluye el FACT-G (General) específico para el cáncer de 27 ítems, que evalúa el bienestar físico, social/familiar, emocional y funcional, además de una subescala de 15 ítems que evalúa preocupaciones específicas del linfoma. Cada elemento se califica en una escala de 0 (nada) a 4 (mucho), lo que arroja una puntuación posible de 0 a 168, donde las puntuaciones más altas representan una mejor CVRS. Este análisis utilizó el análisis de cambio de medida repetida del modelo de efectos mixtos (MMRM) desde el ajuste inicial para las covariables iniciales.	Línea de base, mes 2; línea de base, mes 4; línea de base, mes 6; línea de base, mes 12; línea de base, mes 18; línea de base, mes 24; Línea de base, mes 36
Cambio desde el inicio en la puntuación de EuroQol-5D (EQ-5D) Periodo de tiempo: Línea de base, mes 6; línea de base, mes 24; Línea de base, mes 33	El instrumento EQ-5D es un cuestionario calificado por los participantes que se utiliza para evaluar el estado de salud. El EQ-5D evalúa cinco dimensiones (movilidad, autocuidado, actividad habitual, dolor/malestar y ansiedad/depresión) que los participantes califican utilizando tres niveles (ningún problema, algún problema o problema extremo), así como el estado de salud general . Las cinco dimensiones se pueden combinar usando ponderaciones específicas de cada país para crear una estimación del puntaje general del estado de salud. Los valores posibles para la puntuación van desde -0,594 (problemas graves en las 5 dimensiones) hasta 1 (ningún problema en todas las dimensiones) en una escala en la que 1 representa el mejor estado de salud posible. Este análisis utilizó el análisis de medidas repetidas del modelo de efectos mixtos (MMRM) del cambio desde la línea de base en el EQ-5D para el ajuste de la puntuación del índice basado en la población del Reino Unido para las covariables de la línea de base.	Línea de base, mes 6; línea de base, mes 24; Línea de base, mes 33
Investigación traslacional: participantes de DFS con linfoma difuso de células B grandes (DLBCL) Células B del centro germinal (GCB) versus células B del centro no germinal Periodo de tiempo: Línea de base a 24 meses (2 años)	Se informan los DFS para el estado GCB y no GCB. Los subtipos moleculares de DLBCL de GCB/no-GCB utilizando el algoritmo de Hans se determinaron mediante la expresión de proteínas mediante tinción inmunohistoquímica (IHC) para evaluar la caracterización de subtipos moleculares de GCB y no GCB.	Línea de base a 24 meses (2 años)
Investigación traslacional: DFS de participantes con expresión de la proteína quinasa C-β2 (PKC-β2) del linfoma difuso de células B grandes (DLBCL) Periodo de tiempo: Línea de base a 94,5 meses	Se informa la DFS basada en la expresión de la proteína PKC-β2. La tinción inmunohistoquímica (IHC) se realizó para evaluar la expresión de la proteína PKC-β2 en el citoplasma puntuada para el porcentaje de células tumorales teñidas, y se usó una tinción positiva del 50 % como punto de corte para la expresión alta/baja (expresión alta: >=50 % de tinción, baja expresión: <50% tinción).	Línea de base a 94,5 meses
Farmacocinética: concentración promedio en estado estacionario (Cavg,ss) para el analito total Periodo de tiempo: Mes 2, Mes 4: Predosis		Mes 2, Mes 4: Predosis

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Crump M, Leppa S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, Double-Blind, Phase III Trial of Enzastaurin Versus Placebo in Patients Achieving Remission After First-Line Therapy for High-Risk Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. doi: 10.1200/JCO.2015.65.7171. Epub 2016 May 23.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2006

Finalización primaria (Actual)

1 de abril de 2013

Finalización del estudio (Actual)

1 de julio de 2013

Fechas de registro del estudio

Enviado por primera vez

30 de mayo de 2006

Primero enviado que cumplió con los criterios de control de calidad

30 de mayo de 2006

Publicado por primera vez (Estimar)

1 de junio de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

6 de septiembre de 2018

Última verificación

1 de septiembre de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

9823
PRELUDE (Otro identificador: Eli Lilly and Company)
H6Q-MC-JCBJ (Otro identificador: Eli Lilly and Company)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre No linfoma de Hodgkin

Rutgers, The State University of New Jersey

Terminado

Intervenciones de estrés en STEM y no STEM

MBSR-STEM | PMR-STEM | MBSR-NON-STEM | PMR - SIN VÁSTAGO

Estados Unidos
National Cancer Institute (NCI)

Terminado

Bortezomib, ifosfamida y tartrato de vinorelbina en el tratamiento de pacientes jóvenes con linfoma de Hodgkin recurrente o que no respondió a la terapia previa

Linfoma de Hodgkin en adultos recidivante | Linfoma de Hodgkin en adultos en estadio III | Linfoma de Hodgkin en adultos en estadio IV | Linfoma de Hodgkin infantil recidivante/refractario | Linfoma de Hodgkin infantil en estadio III | Linfoma de Hodgkin infantil en estadio IV | Linfoma de Hodgkin... y otras condiciones

Estados Unidos
University of Washington

Reclutamiento

Brentuximab vedotin con o sin nivolumab en el tratamiento de pacientes con linfoma CD30+ en recaída o refractario

Linfoma de Hodgkin recurrente | Linfoma de Hodgkin refractario | Linfoma no Hodgkin recurrente | Linfoma no Hodgkin refractario

Estados Unidos
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)

Terminado

Yodo I 131 Anticuerpo monoclonal BC8 antes del trasplante autólogo de células madre en el tratamiento de pacientes con linfoma de Hodgkin o linfoma no Hodgkin en recaída o refractario

Linfoma de Hodgkin recurrente | Linfoma de Hodgkin refractario | Linfoma no Hodgkin de células B refractario | Linfoma no Hodgkin de células T refractario | Linfoma no Hodgkin de células B recurrente | Linfoma no Hodgkin de células T recurrente

Estados Unidos
Tomsk National Research Medical Center of the Russian...
Uppsala University

Terminado

Imágenes moleculares de linfoma utilizando tecnecio-99m 1-tio-D-glucosa marcado

Linfoma de Hodgkin en adultos | Linfoma no Hodgkin en adultos

Federación Rusa
Academic and Community Cancer Research United
National Cancer Institute (NCI)

Activo, no reclutando

Nivolumab y Brentuximab Vedotin en el tratamiento de pacientes mayores con linfoma de Hodgkin no tratado

Linfoma de Hodgkin en estadio III de Ann Arbor | Linfoma de Hodgkin en estadio IIIA de Ann Arbor | Linfoma de Hodgkin en estadio IIIB de Ann Arbor | Linfoma de Hodgkin en estadio IV de Ann Arbor | Linfoma de Hodgkin en estadio IVA de Ann Arbor | Linfoma de Hodgkin en estadio IVB de Ann Arbor | Linfoma... y otras condiciones

Estados Unidos
Marker Therapeutics, Inc.

Reclutamiento

Eficacia de MT-601 en pacientes con linfoma recidivante/refractario (APOLLO)

No linfoma de Hodgkin | Linfoma no Hodgkin en adultos | Linfoma no Hodgkin, refractario | Linfoma no Hodgkin en recaída

Estados Unidos
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Activo, no reclutando

Clorhidrato de gemcitabina, clofarabina y busulfán antes del trasplante de células madre de donante en el tratamiento de pacientes con linfoma no Hodgkin de células B o T refractario o linfoma de Hodgkin

Linfoma de Hodgkin refractario | Linfoma no Hodgkin de células B refractario | Linfoma no Hodgkin de células T refractario | Receptor de trasplante de células hematopoyéticas

Estados Unidos
Stanford University
National Institutes of Health (NIH); Amgen

Terminado

Estudios clínicos y patológicos en pacientes con linfoma no Hodgkin que reciben tratamiento con anticuerpos

Linfoma No Hodgkin | Linfomas: no Hodgkin | Linfomas: células T periféricas no Hodgkin | Linfomas: linfoma cutáneo no Hodgkin | Linfomas: células B grandes difusas no Hodgkin | Linfomas: folicular no Hodgkin/células B indolentes | Linfomas: células del manto no Hodgkin | Linfomas: Zona Marginal No... y otras condiciones

Estados Unidos
Tessa Therapeutics

Activo, no reclutando

Estudio de fase 2 que evalúa células CD30.CAR-T autólogas en pacientes con linfoma de Hodgkin en recaída/refractario (CHARIOT)

Linfoma de Hodgkin en adultos | Enfermedad de Hodgkin Recurrente | Enfermedad de Hodgkin refractario | Enfermedad de Hodgkin, Pediátrica

Estados Unidos

PRELUDIO:Estudio para investigar la prevención de la recaída en el linfoma usando enzastaurina diaria

Un estudio clínico de fase 3 para investigar la prevención de la recaída en el linfoma usando enzastaurina diaria

Descripción general del estudio

Estado

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Fechas importantes del estudio

Inicio del estudio

Finalización primaria (Actual)

Finalización del estudio (Actual)

Fechas de registro del estudio

Enviado por primera vez

Primero enviado que cumplió con los criterios de control de calidad

Publicado por primera vez (Estimar)

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

Última actualización enviada que cumplió con los criterios de control de calidad

Última verificación

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Ensayos clínicos sobre No linfoma de Hodgkin

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