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
Phase 2
60 Years
N/A
60 Years
N/A
Not Enrolling
Both
Lymphoma, Large Cell, Diffuse
Both
Lymphoma, Large Cell, Diffuse
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival after 1 year treatment
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
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)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
9819
NCT ID:
NCT00436280
Start Date:
February 2007
Completion Date:
November 2012
Related Keywords:
- Lymphoma, Large Cell, Diffuse
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
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