Viewing Study NCT00003605



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Last Modification Date: 2024-10-26 @ 9:03 AM
Study NCT ID: NCT00003605
Status: WITHDRAWN
Last Update Posted: 2015-08-19
First Post: 1999-11-01

Brief Title: Rituximab Plus Cyclophosphamide in Treating Patients With Indolent Stage III or Stage IV Non-Hodgkins Lymphoma
Sponsor: Hoag Memorial Hospital Presbyterian
Organization: Hoag Memorial Hospital Presbyterian

Study Overview

Official Title: Rituximab Anti-CD20 Monoclonal Antibody Plus Oral Cyclophosphamide as Initial Treatment of Indolent Lymphoma
Status: WITHDRAWN
Status Verified Date: 2015-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: no patient accrual
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy and monoclonal antibody therapy may kill more cancer cells

PURPOSE Phase II trial to study the effectiveness of rituximab plus cyclophosphamide in treating patients who have indolent stage III or stage IV non-Hodgkins lymphoma
Detailed Description: OBJECTIVES I Determine the toxicity associated with cyclophosphamide and rituximab IDEC-C2B8 monoclonal antibody as first line treatment in patients with stage III or IV indolent B-cell lymphoma II Determine the objective tumor response rate and duration of response associated with this first line treatment in these patients III Determine the failure-free and overall survival for these patients IV Compare the response rate and survival rates for patients with indolent lymphoma who were treated with this treatment as the first systemic therapy for their disease with response rates and survival observed for similar patients treated in published trials V Determine the quality of life associated with this treatment in this patient population

OUTLINE This is an open label study Patients receive oral cyclophosphamide daily and rituximab IDEC-C2B8 monoclonal antibody IV on days 1 8 15 and 22 for the first 4-week course Patients then receive oral cyclophosphamide daily and rituximab IV monthly until 2 months beyond maximum response Patients are treated for at least 6 months but no more than 18 months in the absence of disease progression Patients are followed every 3 months for 2 years then every 6 months for the next 2 years and then annually for up to 10 years

PROJECTED ACCRUAL There will be 20-40 patients accrued into this study

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
Secondary IDs
Secondary ID Type Domain Link
NCI-V98-1483 None None None
CBRG-9801 None None None
GENENTECH-CBRG-9801 None None None
NBSG-9801 None None None