NCT00436280

Brief Summary

The primary purpose of this study is to help answer the following research questions:

  • To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer.
  • To assess for any side effects that might be associated with enzastaurin and R-GEMOX .
  • To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body.
  • To look at the level of enzastaurin in the body and how long it remains.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_2

Geographic Reach
3 countries

18 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

Study Start

First participant enrolled

February 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

August 6, 2020

Completed
Last Updated

August 6, 2020

Status Verified

July 1, 2020

Enrollment Period

2.8 years

First QC Date

February 16, 2007

Results QC Date

June 9, 2020

Last Update Submit

July 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment

    PFS is defined as the rate at 1 year from the date of first dose of study drug to the first date of measured PD or death from any cause and was determined using the distribution of overall PFS times. The PFS rate at 1 year was determined using Kaplan-Meier estimates. For participants not known to have died as of the data cut-off date and who do not have PD, PFS was censored at the date of the last progression-free disease assessment.

    First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 1 Year

Secondary Outcomes (10)

  • Overall Response Rate (ORR) - Percentage of Participants Achieving Complete Response (CR) or Complete Response Unconfirmed (CRu) or Partial Response (PR) (Response)

    Baseline to Measured Progressive Disease or Death from Any Cause at End of 4 and 8 Cycles

  • Percent of Participants With Progression-Free Survival (PFS) After 2 Years and 4 Years of Treatment

    First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 2 Years, 4 Years

  • Percent of Participants With Overall Survival (OS) After 1 Year, 2 Years and 4 Years

    First Dose of Study Drug to Death from Any Cause at 1 Year, 2 Years and 4 Years

  • Percent of Participants With Event Free Survival (EFS) After 1 Year, 2 Years and 4 Years

    First Dose of Study Drug to Measured PD, or Start of New Lymphoma Treatment or Death from Any Cause at 1 Year, 2 Years and 4 Years

  • Progression-Free Survival (PFS ) of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-Center B-cells (GCB) Versus Non-GCB Molecular Subtypes (Assessment of Biomarkers Relevant for Enzastaurin)

    Baseline, Cycles 1-4, End of Study

  • +5 more secondary outcomes

Study Arms (1)

Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)

EXPERIMENTAL
Drug: enzastaurinDrug: gemcitabineDrug: rituximabDrug: oxaliplatin

Interventions

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

Also known as: LY317615
Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)

1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles

Also known as: LY188011, Gemzar
Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)

375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles

Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)

100 mg/m², IV, once every two weeks, four to eight 2 week cycles

Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of DLBCL or transformed (cluster differentiation 20 \[CD20\]+) indolent lymphoma
  • Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or participants who have not progressed after stable disease (SD) obtained in 1st- or 2nd-line.
  • Measurable disease (lymph node greater than 1.5 cm)
  • Adequate organ function
  • Greater than or equal to 60 years or less than 60 (but greater than or equal to 18 years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT)

You may not qualify if:

  • Prior Allogeneic transplantation
  • More than 2 prior anticancer treatment regimens
  • Pregnant or breastfeeding
  • Human-immunodeficiency-virus (HIV)associated lymphomas
  • Brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

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.

Créteil, 94010, France

Location

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.

Dijon, 21079, France

Location

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.

Lille, 59037, France

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nice, 06202, France

Location

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.

Nîmes, 30029, France

Location

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.

Paris, 75475, France

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Pessac, 33604, France

Location

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.

Pierre-Bénite, 69495, France

Location

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.

Rouen, 76038, France

Location

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.

Berlin, D-12203, Germany

Location

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.

Bremen, 28205, Germany

Location

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.

Essen, D-4600, Germany

Location

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.

Hamburg, 20099, Germany

Location

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.

Kassel, 34125, Germany

Location

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.

Kiel, 24116, Germany

Location

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.

Mainz, 55131, Germany

Location

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.

Moscow, 125167, Russia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Saint Petersburg, 198255, Russia

Location

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

enzastaurinGemcitabineRituximabOxaliplatin

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic Chemicals

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company

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 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2007

First Posted

February 19, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2012

Last Updated

August 6, 2020

Results First Posted

August 6, 2020

Record last verified: 2020-07

Locations