A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin's Lymphoma (RATE) - Full Text View

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00719472

Purpose

This is a prospective, open-label, Phase III, multicenter, single-arm trial designed to assess the safety, pharmacokinetics, and pharmacodynamics of an alternative dosing rate of rituximab in previously untreated patients with DLBCL and follicular NHL. Approximately 385 patients will be enrolled at approximately 100 centers in the United States in order to achieve at least 350 evaluable patients.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: rituximab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Phase III Multicenter, Open-Label Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Development of a Grade 3 or 4 infusion-related toxicity (targeted adverse event) [ Time Frame: Cycle 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All adverse events regardless of grade or seriousness [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Duration (in minutes) of rituximab administration by cycle [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Rituximab pharmacokinetics as determined by serum rituximab levels during the first rituximab alternative dosing rate (Cycle 2) and the last cycle (either Cycle 6 or 8) of the treatment regimen [ Time Frame: Cycle 2 and the last cycle ] [ Designated as safety issue: No ]
Pharmacodynamics during the first rituximab alternative dosing rate (Cycle 2) and the last cycle (either Cycle 6 or 8) of the treatment regimen [ Time Frame: Cycle 2 and the last cycle ] [ Designated as safety issue: No ]

Estimated Enrollment:	385
Study Start Date:	July 2008
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: rituximab Intravenous repeating dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent
Age ≥ 18 years
Patients with previously untreated DLBCL who are scheduled to receive rituximab 375 mg/m^2 plus CHOP chemotherapy, or previously untreated follicular NHL who are scheduled to receive rituximab 375 mg/m^2 plus CVP chemotherapy

Exclusion Criteria:

Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Classification Grade II or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to Day 1, or NYHA Grade II or greater peripheral vascular disease on Day 1

Patients who meet any of the following criteria will be excluded from further study participation after Cycle 1:

Circulating lymphocyte count >5,000/μL before the Cycle 2 Rituximab infusion
Development of a serious and/or Grade 3 or 4 adverse event during Cycle 1 judged by the investigator to be related to the rituximab infusion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719472

Contacts

Contact: Mark Fisher

fisher.mark-OPER@gene.com

Show 91 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Jamie Hirata, PharmD

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	U4391g
Study First Received:	July 18, 2008
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00719472 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Follicular NHL
NHL
Large B-Cell NHL

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Lymphoma, Follicular

Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010