Chemotherapy for Patients With Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00436280
First received: February 16, 2007
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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 patients with Diffuse Large B-Cell Lymphoma 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.

Condition Intervention Phase
Lymphoma, Large Cell, Diffuse
Drug: enzastaurin
Drug: gemcitabine
Drug: rituximab
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine and Oxaliplatin Plus Enzastaurin as Treatment for Patients With Relapsed Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression Free Survival after 1 year treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Progression Free Survival after 2 and 4 years of treatment [ Time Frame: 2 years, 4 years ] [ Designated as safety issue: No ]
  • Overall Survival after 1, 2 and 4 years [ Time Frame: baseline to death from any cause at 1, 2, and 4 years ] [ Designated as safety issue: Yes ]
  • Event Free Survival after 1, 2 and 4 years [ Time Frame: 1 year, 2 years, 4 years ] [ Designated as safety issue: No ]
  • Assessment of biomarkers relevant for Enzastaurin [ Time Frame: baseline, cycles 1-4, end of study ] [ Designated as safety issue: No ]
  • Characterization of pharmacokinetics of enzastaurin and it's metabolites [ Time Frame: cycles 1-4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: February 2007
Study Completion Date: November 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
Other Name: LY317615
Drug: gemcitabine
1000 mg/m2, IV, once, every two weeks, four to eight 2 week cycles
Other Name: LY188011, Gemzar
Drug: rituximab
375 mg/m2, IV, once every 2 weeks, four to eight 2 week cycles
Drug: oxaliplatin
100 mg/m2, IV, once every two weeks, four to eight 2 week cycles

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of DLBCL or transformed (CD20+) indolent lymphoma
  • Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or patients who have not progressed after 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 HDC and ASCT

Exclusion Criteria:

  • Prior Allogeneic transplantation
  • More than 2 prior anticancer treatment regimens
  • Pregnant or breastfeeding
  • Human-immunodeficiency-virus (HIV)associated lymphomas
  • Brain metastases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436280

Locations
France
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.
Creteil, France, 94010
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, France, 21079
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, France, 59037
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, France, 06202
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.
Nimes, France, 30029
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, France, 75475
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, France, 33604
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 Benite, France, 69495
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, France, 76038
Germany
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, Germany, D-12203
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, Germany, 28205
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, Germany, D-4600
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, Germany, 20099
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, Germany, 34125
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, Germany, 24116
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, Germany, 55131
Russian Federation
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, Russian Federation, 125167
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, Russian Federation, 198255
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00436280     History of Changes
Other Study ID Numbers: 9819, H6Q-MC-S013
Study First Received: February 16, 2007
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Gemcitabine
Oxaliplatin
Rituximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014