Viewing Study NCT00003820



Ignite Creation Date: 2024-05-05 @ 9:57 AM
Last Modification Date: 2024-10-26 @ 9:04 AM
Study NCT ID: NCT00003820
Status: COMPLETED
Last Update Posted: 2017-04-20
First Post: 1999-11-01

Brief Title: Rituximab in Treating Patients With Hodgkins Lymphoma
Sponsor: Ranjana Advani
Organization: Stanford University

Study Overview

Official Title: Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkins Disease
Status: COMPLETED
Status Verified Date: 2017-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkins lymphoma
Detailed Description: This study will evaluate the partial complete and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkins lymphoma Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6 12 and 18 months

This was a single-arm study with multiple treatment periods added by amendment ie Secondary Group with results reported by treatment period As this was always considered a single-arm study there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
LYMHD0003 OTHER OnCore None
75967 OTHER None None
U2082N None None None