Non Hodgkin LymphomaPhase 3NCT00332202

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

A Phase 3 study testing enzastaurin in people with Non Hodgkin Lymphoma, run by Eli Lilly and Company at 153 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Hodgkin Lymphoma
What is being tested?: enzastaurin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 758 participants
Where: 153 sitesin 25 countries
Study dates: Jun 2006to Jul 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

153 sites in 25 countries.

Country

City, postcode or hospital

153 sites in 25 countries

United States24 sites

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Anchorage, Alaska, 99508
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Bloomington, Indiana, 47402
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Boston, Massachusetts, 02115
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Chicago, Illinois, 60637
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Columbia, Missouri, 65201
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Durham, North Carolina, 27710
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Everett, Washington, 98201
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Houston, Texas, 77030
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Indianapolis, Indiana, 46202
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Iowa City, Iowa, 52242
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Lexington, Kentucky, 40536
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Los Angeles, California, 90095
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Madison, Wisconsin, 53792
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Memphis, Tennessee, 38138
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Orlando, Florida, 32806
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Pittsburgh, Pennsylvania, 15232
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Robbinsdale, Minnesota, 55422
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Rochester, Minnesota, 55905
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Salt Lake City, Utah, 84103
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Seattle, Washington, 98104
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St Louis, Missouri, 63131
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The Woodlands, Texas, 77380
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Tulsa, Oklahoma, 74136
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Vancouver, Washington, 98686

Other trials in United States

Japan11 sites

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Aichi, 460-0001
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Fukuoka, 811-1395
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Gunma, 371-8511
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Kanagawa, 259-1193
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Kyoto, 602-8566
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Mie, 514-8507
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Miyagi, 980-8574
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Nagasaki, 852-8501
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Okayama, 710-8602
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Shiga, 524-8524
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Tokyo, 141

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France10 sites

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Avignon, 84902
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Bayonne, 64109
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La Roche-sur-Yon, 85925
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Le Mans, 72000
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Nantes, 44202
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Nice, 06202
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Nîmes, 30029
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Pessac, 33604
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Rennes, 35033
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Vandœuvre-lès-Nancy, 54511

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Germany10 sites

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Berlin, 13353
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Chemnitz, 09113
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Erlangen, 91054
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Frankfurt, D-65929
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Giessen, 35392
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Hamburg, 20099
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Homburg, 66421
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Kassel, 34125
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Mainz, 55131
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München, 81675

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Italy8 sites

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Aviano, 33081
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Bergamo, 24128
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Bologna, 40138
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Milan, 20162
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Pisa, 56100
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Reggio Emilia, 42100
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Rome, 00161
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Vicenza, 36100

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Spain8 sites

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Hospitalet Llobregat, 08907
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Madrid, 28041
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Oviedo, 33006
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Salamanca, 37007
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Santander, 39008
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Toledo, 45004
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Valencia, 46009
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Zaragoza, 50009

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Taiwan8 sites

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Changhua, 500
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Chiayi City, 600
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Kaohsiung City, 807
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Liouying/Tainan, 736
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Neihu Taipei, 114
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Taichung, 404
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Tainan, 70403
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Taipei, 220

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Australia7 sites

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Casuarina, Northern Territory, 0811
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Garran, Australian Capital Territory, 2605
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Gosford, New South Wales, 2250
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Heidelberg, Victoria, 3084
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Nedlands, Western Australia, 6009
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Prahran, Victoria, 3181
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Woolloongabba, Queensland, 4102

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China7 sites

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Beijing, 100083
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Chengdu, 610041
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Guangzhou, 510080
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Hangzhou, 310003
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Nanjing, 210029
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Shanghai, 200032
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Suzhou, 215006

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Canada6 sites

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Edmonton, Alberta, T6G 1Z2
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Hamilton, Ontario, L8V 5C2
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Montreal, Quebec, H3T 1E2
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Regina, Saskatchewan, S4T 7T1
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Toronto, Ontario, M5G 2M9
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Vancouver, British Columbia, V5Z 4E6

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Mexico6 sites

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Col. Florida, 01030
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Guadalajara, 44280
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Mexico City, 01120
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Monterrey, 64710
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San Luis Potosí City, 78216
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Toluca, 50180

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United Kingdom6 sites

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Aberdeen, Scotland, AB25 2ZN
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Brighton, East Sussex, BN2 5BE
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Glasgow, Scotland, G12 0YN
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London, SE1 9RT
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Maidstone, Kent, ME16 9QQ
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Plymouth, Devon, PL6 8DH

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Belgium5 sites

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Bruges, 8000
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Brussels, 1000
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Ghent, 9000
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Leuven, 3000
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Roeselare, 8800

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Brazil5 sites

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Belo Horizonte, 30380-490
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Campinas, 13083970
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Goiânia, 74075040
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Rio de Janeiro, 22260020
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São Paulo, 01223001

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India5 sites

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Mumbai, 400 026
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New Delhi, 110017
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Pune, 411004
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Secunderabad, 500003
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Trivandrum, 695 011

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Poland5 sites

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Lublin, 20-090
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Olsztyn, 10-228
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Poznan, 60-569
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Warsaw, 02-781
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Wroclaw, 50-367

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South Korea4 sites

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Daegu, 700-721
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Goyang-si, 411-764
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Hwasun-Gun, 519-809
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Seoul, 138-736

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Czechia3 sites

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Brno, 62500
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Olomouc, 775 20
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Prague, 128 08

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Greece3 sites

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Athens, 11527
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Haidari/Athens, 12462
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Thessaloniki, 54007

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Portugal3 sites

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Coimbra, 3000-075
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Lisbon, 1649-035
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Santa Maria da Feira, 4520-211

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Sweden3 sites

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Lund, 221 85
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Umeå, 901 85
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Uppsala, 75185

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Denmark2 sites

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Herlev, 2730
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Odense, 5000

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Hungary2 sites

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Budapest, 1122
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Miskolc, 3529

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Finland1 site

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Helsinki, 00290

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Puerto Rico1 site

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San Juan, 00918

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About this study

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

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.

Conditions: Non Hodgkin Lymphoma
Being tested: enzastaurin, placebo
Medical subject headings: Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

enzastaurinDrug
Also called LY317615
1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years
placeboDrug
oral, daily

Study groups in NCT00332202
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: enzastaurin
B	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

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.
Measured: Baseline to 2 Years
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.
Measured: Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)
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.
Measured: Baseline to 2 Years
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.
Measured: Baseline to Date of Death from Any Cause (up to 80.30 months)
Number of Participants With Treatment-Emergent Adverse Events
Number of participants with treatment-emergent adverse events.
Measured: First dose through 30 days post-study treatment discontinuation (up to 81.30 months)
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.
Measured: Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36
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.
Measured: Baseline, Month 6; Baseline, Month 24; Baseline, Month 33
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.
Measured: Baseline to 24 months (2 years)
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).
Measured: Baseline to 94.5 months
Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte
Measured: Month 2, Month 4: Predose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Jul 2013

First posted1 Jun 2006 (estimated)
Study startJun 2006
Primary completionApr 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 758 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00332202
Sponsor's protocol ID: 9823
Other IDs: H6Q-MC-JCBJ, PRELUDE
Status last verified: Sep 2018
First submitted: 30 May 2006
Last updated: 10 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 27217449

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
ClinicalTrials.gov ID: NCT00332202
Acronym / sponsor ID: 9823
Conditions: Non Hodgkin Lymphoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 758 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Apr 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 1 Jun 2006 (estimated)
Results: Posted 10 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: enzastaurin
B	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
enzastaurinAlso: LY3176151125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years	Drug	A
placebooral, daily	Drug	B

Primary outcome

Overall Disease-Free Survival
Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)
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.

10 secondary outcomes

Disease Free Survival at 2 Years
Time frame: Baseline to 2 Years
Event-Free Survival
Time frame: Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)
Event-Free Survival at 2 Years
Time frame: Baseline to 2 Years
Overall Survival
Time frame: Baseline to Date of Death from Any Cause (up to 80.30 months)
Number of Participants With Treatment-Emergent Adverse Events
Time frame: First dose through 30 days post-study treatment discontinuation (up to 81.30 months)
Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score
Time frame: Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36
Change From Baseline in EuroQol-5D (EQ-5D) Score
Time frame: Baseline, Month 6; Baseline, Month 24; Baseline, Month 33
Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells
Time frame: Baseline to 24 months (2 years)
Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression
Time frame: Baseline to 94.5 months
Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte
Time frame: Month 2, Month 4: Predose

Results and safety

Results posted to the registry on 10 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enzastaurin: Arm A - Experimental	504	263
Placebo: Arm B - Control	254	129

Primary outcome: Overall Disease-Free Survival

Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months). Median (95% Confidence Interval). Unit: Month

Measure	Enzastaurin: Arm A - Experimental n = 504	Placebo: Arm B - Control n = 254
Value	42.8 (0.03 to 76.81)	43.1 (0.03 to 80.30)

Enzastaurin: Arm A - Experimental vs Placebo: Arm B - Control: Hazard Ratio (HR): 0.92 (95% CI 0.689 to 1.216), p = 0.541, Log Rank

Population analysed: All randomized participants. DFS is censored at the last assessable disease free assessment for participants who are alive or have not progressed. The number of censored participant data for enzastaurin and placebo is 369 (73.2%) and 180 (70.9%), respectively.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enzastaurin: Arm A - Experimental	135 of 493 (27.4%)	406 of 493 (82.4%)	Not reported
Placebo: Arm B - Control	72 of 249 (28.9%)	185 of 249 (74.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27217449Crump 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.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

153 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing enzastaurin in people with Non Hodgkin Lymphoma, run by Eli Lilly and Company at 153 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, Japan, France, Germany, Italy and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Disease-Free Survival (time frame: Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00332202, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.