NCT00332202

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
758

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_3

Geographic Reach
25 countries

153 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

September 10, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

6.8 years

First QC Date

May 30, 2006

Results QC Date

May 30, 2018

Last Update Submit

September 6, 2018

Conditions

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (10)

  • Disease Free Survival at 2 Years

    Baseline to 2 Years

  • Event-Free Survival

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

  • Event-Free Survival at 2 Years

    Baseline to 2 Years

  • Overall Survival

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

  • Number of Participants With Treatment-Emergent Adverse Events

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

  • +5 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: enzastaurin

B

PLACEBO COMPARATOR
Drug: placebo

Interventions

enzastaurinDRUG

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

Also known as: LY317615
A
placeboDRUG

oral, daily

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (153)

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Anchorage, Alaska, 99508, United States

Location

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Los Angeles, California, 90095, United States

Location

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Orlando, Florida, 32806, United States

Location

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Chicago, Illinois, 60637, United States

Location

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Bloomington, Indiana, 47402, United States

Location

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Indianapolis, Indiana, 46202, United States

Location

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Iowa City, Iowa, 52242, United States

Location

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Lexington, Kentucky, 40536, United States

Location

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Boston, Massachusetts, 02115, United States

Location

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Robbinsdale, Minnesota, 55422, United States

Location

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Rochester, Minnesota, 55905, United States

Location

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Columbia, Missouri, 65201, United States

Location

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St Louis, Missouri, 63131, United States

Location

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Durham, North Carolina, 27710, United States

Location

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Tulsa, Oklahoma, 74136, United States

Location

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Pittsburgh, Pennsylvania, 15232, United States

Location

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Memphis, Tennessee, 38138, United States

Location

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Houston, Texas, 77030, United States

Location

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The Woodlands, Texas, 77380, United States

Location

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Salt Lake City, Utah, 84103, United States

Location

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Everett, Washington, 98201, United States

Location

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Seattle, Washington, 98104, United States

Location

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Vancouver, Washington, 98686, United States

Location

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Madison, Wisconsin, 53792, United States

Location

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Garran, Australian Capital Territory, 2605, Australia

Location

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Gosford, New South Wales, 2250, Australia

Location

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Casuarina, Northern Territory, 0811, Australia

Location

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Woolloongabba, Queensland, 4102, Australia

Location

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Heidelberg, Victoria, 3084, Australia

Location

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Prahran, Victoria, 3181, Australia

Location

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Nedlands, Western Australia, 6009, Australia

Location

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Bruges, 8000, Belgium

Location

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Brussels, 1000, Belgium

Location

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Ghent, 9000, Belgium

Location

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Leuven, 3000, Belgium

Location

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Roeselare, 8800, Belgium

Location

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Belo Horizonte, 30380-490, Brazil

Location

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Campinas, 13083970, Brazil

Location

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Goiânia, 74075040, Brazil

Location

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Rio de Janeiro, 22260020, Brazil

Location

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São Paulo, 01223001, Brazil

Location

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Edmonton, Alberta, T6G 1Z2, Canada

Location

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Vancouver, British Columbia, V5Z 4E6, Canada

Location

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Hamilton, Ontario, L8V 5C2, Canada

Location

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Toronto, Ontario, M5G 2M9, Canada

Location

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Montreal, Quebec, H3T 1E2, Canada

Location

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Regina, Saskatchewan, S4T 7T1, Canada

Location

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Beijing, 100083, China

Location

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Chengdu, 610041, China

Location

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Guangzhou, 510080, China

Location

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Hangzhou, 310003, China

Location

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Nanjing, 210029, China

Location

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Shanghai, 200032, China

Location

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Suzhou, 215006, China

Location

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Brno, 62500, Czechia

Location

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Olomouc, 775 20, Czechia

Location

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Prague, 128 08, Czechia

Location

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Herlev, 2730, Denmark

Location

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Odense, 5000, Denmark

Location

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Helsinki, 00290, Finland

Location

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Avignon, 84902, France

Location

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Bayonne, 64109, France

Location

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La Roche-sur-Yon, 85925, France

Location

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Le Mans, 72000, France

Location

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Nantes, 44202, France

Location

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Nice, 06202, France

Location

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Nîmes, 30029, France

Location

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Pessac, 33604, France

Location

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Rennes, 35033, France

Location

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Vandœuvre-lès-Nancy, 54511, France

Location

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Berlin, 13353, Germany

Location

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Chemnitz, 09113, Germany

Location

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Erlangen, 91054, Germany

Location

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Frankfurt, D-65929, Germany

Location

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Giessen, 35392, Germany

Location

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Hamburg, 20099, Germany

Location

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Homburg, 66421, Germany

Location

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Kassel, 34125, Germany

Location

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Mainz, 55131, Germany

Location

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München, 81675, Germany

Location

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Athens, 11527, Greece

Location

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Haidari/Athens, 12462, Greece

Location

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Thessaloniki, 54007, Greece

Location

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Budapest, 1122, Hungary

Location

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Miskolc, 3529, Hungary

Location

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Mumbai, 400 026, India

Location

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New Delhi, 110017, India

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Pune, 411004, India

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Secunderabad, 500003, India

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Trivandrum, 695 011, India

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Aviano, 33081, Italy

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Bergamo, 24128, Italy

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Bologna, 40138, Italy

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Milan, 20162, Italy

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Pisa, 56100, Italy

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Reggio Emilia, 42100, Italy

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Rome, 00161, Italy

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Vicenza, 36100, Italy

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Aichi, 460-0001, Japan

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Fukuoka, 811-1395, Japan

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Gunma, 371-8511, Japan

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Kanagawa, 259-1193, Japan

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Kyoto, 602-8566, Japan

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Mie, 514-8507, Japan

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Miyagi, 980-8574, Japan

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Nagasaki, 852-8501, Japan

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Okayama, 710-8602, Japan

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Shiga, 524-8524, Japan

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Tokyo, 141, Japan

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Col. Florida, 01030, Mexico

Location

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Guadalajara, 44280, Mexico

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Mexico City, 01120, Mexico

Location

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Monterrey, 64710, Mexico

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San Luis Potosí City, 78216, Mexico

Location

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Toluca, 50180, Mexico

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Lublin, 20-090, Poland

Location

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Olsztyn, 10-228, Poland

Location

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Poznan, 60-569, Poland

Location

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Warsaw, 02-781, Poland

Location

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Wroclaw, 50-367, Poland

Location

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Coimbra, 3000-075, Portugal

Location

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Lisbon, 1649-035, Portugal

Location

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Santa Maria da Feira, 4520-211, Portugal

Location

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San Juan, 00918, Puerto Rico

Location

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Daegu, 700-721, South Korea

Location

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Goyang-si, 411-764, South Korea

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Hwasun-Gun, 519-809, South Korea

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Seoul, 138-736, South Korea

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Hospitalet Llobregat, 08907, Spain

Location

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Madrid, 28041, Spain

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Oviedo, 33006, Spain

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Salamanca, 37007, Spain

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Santander, 39008, Spain

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Toledo, 45004, Spain

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Valencia, 46009, Spain

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Zaragoza, 50009, Spain

Location

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Lund, 221 85, Sweden

Location

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Umeå, 901 85, Sweden

Location

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Uppsala, 75185, Sweden

Location

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Changhua, 500, Taiwan

Location

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Chiayi City, 600, Taiwan

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Kaohsiung City, 807, Taiwan

Location

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Liouying/Tainan, 736, Taiwan

Location

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Neihu Taipei, 114, Taiwan

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Taichung, 404, Taiwan

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Tainan, 70403, Taiwan

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Taipei, 220, Taiwan

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Plymouth, Devon, PL6 8DH, United Kingdom

Location

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Brighton, East Sussex, BN2 5BE, United Kingdom

Location

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Maidstone, Kent, ME16 9QQ, United Kingdom

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Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

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Glasgow, Scotland, G12 0YN, United Kingdom

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London, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 27217449DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

enzastaurin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2006

First Posted

June 1, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2013

Study Completion

July 1, 2013

Last Updated

September 10, 2018

Results First Posted

September 10, 2018

Record last verified: 2018-09

Locations

BE(5)CA(6)DE(10)FI(1)CZ(3)FR(10)GR(3)HU(2)US(24)AU(7)DK(2)KR(4)ES(8)TW(8)SE(3)PL(5)IT(8)IN(5)JP(11)PR(1)GB(6)CN(7)BR(5)ME(6)PT(3)