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PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

Primary Purpose

Non Hodgkin Lymphoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

enzastaurin

placebo

About this trial

This is an interventional prevention trial for Non Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

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.
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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.
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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.
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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.
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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.
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.
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.
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Overall Disease-Free Survival

Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.

Secondary Outcome Measures

Disease Free Survival at 2 Years

Disease-free survival at 2 years (DFS2) is defined as the rate of DFS at 2 years from the date of study enrollment and is determined using the distribution of overall DFS times. Disease-free survival rates at 2 years will be estimated using the Kaplan-Meier method.

Event-Free Survival

Overall Event-Free Survival (EFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease), institution of a new anti-cancer treatment, or death from any cause. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.

Event-Free Survival at 2 Years

Event-Free Survival at 2 years (EFS2) is defined as the rate of EFS at 2 years from the date of study enrollment and is determined using the distribution of overall EFS times. Event-free survival rates at 2 years will be estimated using the Kaplan-Meier method.

Overall Survival

Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause.

Number of Participants With Treatment-Emergent Adverse Events

Number of participants with treatment-emergent adverse events.

Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score

The FACT-Lym assesses health-related quality of life (HRQoL) in participants with non-Hodgkin lymphoma. It includes the 27-item cancer-specific FACT-G (General), which assesses physical, social/family, emotional and functional well-being, plus a 15-item subscale that assesses concerns specific to lymphoma. Each item is scored on a scale from 0 (not at all) to 4 (very much), yielding a possible score of 0-168, with higher scores representing better HRQoL. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline adjusting for baseline covariates.

Change From Baseline in EuroQol-5D (EQ-5D) Score

The EQ-5D instrument is a participant-rated questionnaire used to evaluate health status. The EQ-5D assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) that participants rate using three levels (no problem, some problem, or extreme problem), as well as overall health status. The five dimensions can be combined using country-specific weights to create an estimate of overall health status score. The possible values for score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline in the EQ-5D for the United Kingdom population-based index score adjusting for baseline covariates.

Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells

Reported are the DFS for GCB and non-GCB status. DLBCL molecular subtypes of GCB/non-GCB using Hans' algorithm were determined by protein expression by immunohistochemistry (IHC) staining was used to assess molecular subtype characterization of GCB and non-GCB.

Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression

Reported are the DFS based on PKC-β2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm scored for percent of tumor cells stained, and using 50% positive staining as the cutoff for high/low expression (high expression: >=50% staining, low expression: <50% staining).

Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte

Full Information

NCT ID

NCT00332202

First Posted

May 30, 2006

Last Updated

September 6, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00332202

Brief Title

PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

Official Title

A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Hodgkin Lymphoma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

758 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

enzastaurin

Other Intervention Name(s)

LY317615

Intervention Description

1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral, daily

Primary Outcome Measure Information:

Title

Overall Disease-Free Survival

Description

Time Frame

Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)

Secondary Outcome Measure Information:

Title

Disease Free Survival at 2 Years

Description

Time Frame

Baseline to 2 Years

Title

Event-Free Survival

Description

Time Frame

Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)

Title

Event-Free Survival at 2 Years

Description

Time Frame

Baseline to 2 Years

Title

Overall Survival

Description

Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause.

Time Frame

Baseline to Date of Death from Any Cause (up to 80.30 months)

Title

Number of Participants With Treatment-Emergent Adverse Events

Description

Number of participants with treatment-emergent adverse events.

Time Frame

First dose through 30 days post-study treatment discontinuation (up to 81.30 months)

Title

Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score

Description

Time Frame

Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36

Title

Change From Baseline in EuroQol-5D (EQ-5D) Score

Description

Time Frame

Baseline, Month 6; Baseline, Month 24; Baseline, Month 33

Title

Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells

Description

Time Frame

Baseline to 24 months (2 years)

Title

Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression

Description

Time Frame

Baseline to 94.5 months

Title

Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte

Time Frame

Month 2, Month 4: Predose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

City

Bloomington

State/Province

Indiana

ZIP/Postal Code

47402

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

City

Robbinsdale

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65201

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84103

Country

United States

Facility Name

City

Everett

State/Province

Washington

ZIP/Postal Code

98201

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98686

Country

United States

Facility Name

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

City

Garran

State/Province

Australian Capital Territory

ZIP/Postal Code

2605

Country

Australia

Facility Name

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

City

Casuarina

State/Province

Northern Territory

ZIP/Postal Code

0811

Country

Australia

Facility Name

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

City

Belo Horizonte

ZIP/Postal Code

30380-490

Country

Brazil

Facility Name

City

Campinas

ZIP/Postal Code

13083970

Country

Brazil

Facility Name

City

Goiania

ZIP/Postal Code

74075040

Country

Brazil

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

22260020

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

01223001

Country

Brazil

Facility Name

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 7T1

Country

Canada

Facility Name

City

Beijing

ZIP/Postal Code

100083

Country

China

Facility Name

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

City

Guang Zhou

ZIP/Postal Code

510080

Country

China

Facility Name

City

Hangzhou

ZIP/Postal Code

310003

Country

China

Facility Name

City

Nanjing

ZIP/Postal Code

210029

Country

China

Facility Name

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

City

Suzhou

ZIP/Postal Code

215006

Country

China

Facility Name

City

Brno

ZIP/Postal Code

62500

Country

Czechia

Facility Name

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

City

Prague

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

City

Avignon

ZIP/Postal Code

84902

Country

France

Facility Name

City

Bayonne

ZIP/Postal Code

64109

Country

France

Facility Name

City

La Roche Sur Yon

ZIP/Postal Code

85925

Country

France

Facility Name

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

City

Nantes

ZIP/Postal Code

44202

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

City

Chemnitz

ZIP/Postal Code

09113

Country

Germany

Facility Name

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

City

Frankfurt

ZIP/Postal Code

D-65929

Country

Germany

Facility Name

City

Giessen

ZIP/Postal Code

35392

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

City

Kassel

ZIP/Postal Code

34125

Country

Germany

Facility Name

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

City

Haidari/Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

City

Thessaloniki

ZIP/Postal Code

54007

Country

Greece

Facility Name

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

City

Mumbai

ZIP/Postal Code

400 026

Country

India

Facility Name

City

New Delhi

ZIP/Postal Code

110017

Country

India

Facility Name

City

Pune

ZIP/Postal Code

411004

Country

India

Facility Name

City

Secunderabad

ZIP/Postal Code

500003

Country

India

Facility Name

City

Trivandrum

ZIP/Postal Code

695 011

Country

India

Facility Name

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Facility Name

City

Bergamo

ZIP/Postal Code

24128

Country

Italy

Facility Name

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

City

Pisa

ZIP/Postal Code

56100

Country

Italy

Facility Name

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

City

Vicenza

ZIP/Postal Code

36100

Country

Italy

Facility Name

City

Aichi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

City

Gunma

ZIP/Postal Code

371-8511

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

259-1193

Country

Japan

Facility Name

City

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

City

Mie

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

City

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

City

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

City

Okayama

ZIP/Postal Code

710-8602

Country

Japan

Facility Name

City

Shiga

ZIP/Postal Code

524-8524

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

141

Country

Japan

Facility Name

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

Facility Name

City

Goyang-Si

ZIP/Postal Code

411-764

Country

Korea, Republic of

Facility Name

City

Hwasun-Gun

ZIP/Postal Code

519-809

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

City

Col. Florida

ZIP/Postal Code

01030

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44280

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

01120

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64710

Country

Mexico

Facility Name

City

San Luis Potosi

ZIP/Postal Code

78216

Country

Mexico

Facility Name

City

Toluca

ZIP/Postal Code

50180

Country

Mexico

Facility Name

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-781

Country

Poland

Facility Name

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

City

Lisbon

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

City

Santa Maria Da Feira

ZIP/Postal Code

4520-211

Country

Portugal

Facility Name

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

City

Hospitalet Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

City

Toledo

ZIP/Postal Code

45004

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

City

Umea

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

City

Chiayi City

ZIP/Postal Code

600

Country

Taiwan

Facility Name

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

City

Liouying/Tainan

ZIP/Postal Code

736

Country

Taiwan

Facility Name

City

Neihu Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

220

Country

Taiwan

Facility Name

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

City

Brighton

State/Province

East Sussex

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

Facility Name

City

Maidstone

State/Province

Kent

ZIP/Postal Code

ME16 9QQ

Country

United Kingdom

Facility Name

City

Aberdeen

State/Province

Scotland

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27217449

Citation

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.

Results Reference

derived

Learn more about this trial

PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

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