Back to resultsMonoclonal Antibody Treatment for Non-Hodgkin's Lymphoma (Low-Grade)
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
epratuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma
Eligibility Criteria
Diagnosis of relapsed or refractory low-grade, CD20+, B-cell NHL * Received and failed at least 1 prior regimen of chemotherapy * Rituximab-naive or received prior rituximab in their last treatment (single agent or in combination with chemotherapy) and demonstrated a time to progression of at least 12 months.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00044902
Brief Title
Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma (Low-Grade)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
Epratuzumab is currently being studied in combination with rituximab, for the treatment of patients with low-grade NHL who failed previous chemotherapy and have never received rituximab or who received rituximab as a single agent or in combination with chemotherapy as their last treatment and who demonstrated a partial response or complete response for at least 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
epratuzumab
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis of relapsed or refractory low-grade, CD20+, B-cell NHL * Received and failed at least 1 prior regimen of chemotherapy * Rituximab-naive or received prior rituximab in their last treatment (single agent or in combination with chemotherapy) and demonstrated a time to progression of at least 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma (Low-Grade)
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