Viewing Study NCT00077961



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Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00077961
Status: TERMINATED
Last Update Posted: 2015-03-26
First Post: 2004-02-13

Brief Title: Rituximab Plus CAMPATH in Patients With RelapsedRefractory Low-Grade or Follicular CD20-positive B-cell NHL
Sponsor: Genzyme a Sanofi Company
Organization: Sanofi

Study Overview

Official Title: Phase III Study of Rituximab Plus CAMPATH in Patients With Previously Treated Relapsed or Refractory Low-Grade Follicular CD20-positive B-cell Non-Hodgkins Lymphoma
Status: TERMINATED
Status Verified Date: 2015-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory low-grade or follicular CD-20-positive B-Cell non-Hodgkins Lymphoma Safety will be the primary objective of phase I while the primary objective of phase II will be to determine overall response
Detailed Description: This study is being conducted in 2 parts Phase I will involve dose escalation of subcutaneous CAMPATH SQ given 3 times per week in combination with weekly doses of rituximab 375mgm2 for a maximum of 8 weeks in order to determine the maximum tolerated dose MTD In Phase II patients will be treated with SQ CAMPATH at the MTD plus weekly rituximab 375mgm2for a maximum of 8 weeks with primary objective of defining Overall Response OR to this combination

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None