PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
NCT ID: NCT00332202
Last Updated: 2018-09-10
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
758 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-06-30
Study Completion Date
2013-07-31
Brief Summary
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This clinical research study is to investigate the prevention of relapse in patients with diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.
This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.
This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.
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Detailed Description
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Conditions
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Non Hodgkin Lymphoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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A
Group Type
EXPERIMENTAL
enzastaurin
Intervention Type
DRUG
1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years
B
Group Type
PLACEBO_COMPARATOR
placebo
Intervention Type
DRUG
oral, daily
Interventions
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enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years
Intervention Type
DRUG
placebo
oral, daily
Intervention Type
DRUG
Other Intervention Names
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LY317615
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of diffuse large B cell lymphoma
* Recently completed R-CHOP therapy and achieved remission
* International Prognostic Index (IPI) score 3,4,5
* At least 18 years of age
* Agree to study follow-up schedule
* Recently completed R-CHOP therapy and achieved remission
* International Prognostic Index (IPI) score 3,4,5
* At least 18 years of age
* Agree to study follow-up schedule
Exclusion Criteria
* Have received therapy other than R-CHOP for lymphoma
* Serious medical condition such as infection,second cancer,heart disease
* Received radiation to more than one lesion
* Unable to swallow tablets
* Serious medical condition such as infection,second cancer,heart disease
* Received radiation to more than one lesion
* Unable to swallow tablets
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Anchorage, Alaska, United States
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Los Angeles, California, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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Bloomington, Indiana, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Lexington, Kentucky, United States
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Boston, Massachusetts, United States
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Robbinsdale, Minnesota, United States
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Rochester, Minnesota, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Durham, North Carolina, United States
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Tulsa, Oklahoma, United States
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Houston, Texas, United States
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The Woodlands, Texas, United States
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Everett, Washington, United States
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Garran, Australian Capital Territory, Australia
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Gosford, New South Wales, Australia
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Casuarina, Northern Territory, Australia
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Woolloongabba, Queensland, Australia
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Heidelberg, Victoria, Australia
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Nedlands, Western Australia, Australia
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Bruges, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Belo Horizonte, , Brazil
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Campinas, , Brazil
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Goiânia, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Regina, Saskatchewan, Canada
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Beijing, , China
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Chengdu, , China
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Guangzhou, , China
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Hangzhou, , China
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Nanjing, , China
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Shanghai, , China
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Suzhou, , China
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Brno, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Herlev, , Denmark
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Odense, , Denmark
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Helsinki, , Finland
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Avignon, , France
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Bayonne, , France
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La Roche-sur-Yon, , France
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Le Mans, , France
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Nantes, , France
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Nice, , France
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Nîmes, , France
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Pessac, , France
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Rennes, , France
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Vandœuvre-lès-Nancy, , France
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Berlin, , Germany
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Chemnitz, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Giessen, , Germany
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Hamburg, , Germany
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Homburg, , Germany
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Kassel, , Germany
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Mainz, , Germany
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München, , Germany
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Athens, , Greece
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Haidari/Athens, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Miskolc, , Hungary
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Mumbai, , India
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New Delhi, , India
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Pune, , India
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Secunderabad, , India
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Trivandrum, , India
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Aviano, , Italy
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Bergamo, , Italy
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Bologna, , Italy
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Milan, , Italy
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Pisa, , Italy
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Reggio Emilia, , Italy
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Rome, , Italy
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Vicenza, , Italy
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Aichi, , Japan
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Fukuoka, , Japan
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Gunma, , Japan
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Kanagawa, , Japan
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Kyoto, , Japan
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Mie, , Japan
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Miyagi, , Japan
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Nagasaki, , Japan
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Okayama, , Japan
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Shiga, , Japan
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Tokyo, , Japan
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Col. Florida, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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San Luis Potosí City, , Mexico
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Toluca, , Mexico
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Lublin, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Santa Maria da Feira, , Portugal
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San Juan, , Puerto Rico
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Daegu, , South Korea
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Goyang-si, , South Korea
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Hwasun-Gun, , South Korea
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Seoul, , South Korea
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Hospitalet Llobregat, , Spain
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Madrid, , Spain
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Oviedo, , Spain
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Salamanca, , Spain
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Santander, , Spain
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Toledo, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Lund, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
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Changhua, , Taiwan
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Chiayi City, , Taiwan
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Kaohsiung City, , Taiwan
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Liouying/Tainan, , Taiwan
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Neihu Taipei, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Plymouth, Devon, United Kingdom
Site Status
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Brighton, East Sussex, United Kingdom
Site Status
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Maidstone, Kent, United Kingdom
Site Status
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Aberdeen, Scotland, United Kingdom
Site Status
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Glasgow, Scotland, United Kingdom
Site Status
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London, , United Kingdom
Site Status
Countries
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United States
Australia
Belgium
Brazil
Canada
China
Czechia
Denmark
Finland
France
Germany
Greece
Hungary
India
Italy
Japan
Mexico
Poland
Portugal
Puerto Rico
South Korea
Spain
Sweden
Taiwan
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
Other Identifiers
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H6Q-MC-JCBJ
Identifier Type: OTHER
Identifier Source: secondary_id
PRELUDE
Identifier Type: OTHER
Identifier Source: secondary_id
9823
Identifier Type: -
Identifier Source: org_study_id
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