Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma (Low-Grade) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 6, 2002

Last Updated Date

December 20, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00044902 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Monoclonal Antibody Treatment for Non-Hodgkin's Lymphoma (Low-Grade)

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Non-Hodgkin's Lymphoma

Intervention ^ICMJE

Drug: epratuzumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00044902

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20010138

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP