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 (Responsible Party):	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:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 ]

Enrollment:	451
Study Start Date:	July 2008
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Deborah Hurst, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT00719472 History of Changes
Other Study ID Numbers:	U4391g
Study First Received:	July 18, 2008
Last Updated:	December 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Follicular NHL
NHL
Large B-Cell NHL

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012