Clinical trial NCT00719472: A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Keywords: Follicular NHL
NHL
Large B-Cell NHL
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was 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 diffuse large B-cell lymphoma (DLBCL) and follicular non-Hodgkin lymphoma (NHL).


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age ≥ 18 years
* Patients with previously untreated diffuse large B-cell lymphoma (DLBCL) who are scheduled to receive rituximab 375 mg/m\^2 plus CHOP (cyclophosphamide, hydroxydaunorubicin \[also called doxorubicin or adriamycin\], Oncovin \[vincristine\], prednisone or prednisolone) chemotherapy, or previously untreated follicular non-Hodgkin lymphoma (NHL) who are scheduled to receive rituximab 375 mg/m\^2 plus CVP (cyclophosphamide, vincristine, prednisolone) chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

\* Clinically significant cardiovascular disease (eg, 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 (first day of treatment)

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
* Prior premedication with additional corticosteroids other than the prednisone included in the chemotherapy regimens

Primary outcomes:
measure: Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2
timeFrame: Days 1 and 2 of Cycle 2
Secondary outcomes:
measure: Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1
timeFrame: Cycle 1
measure: Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)
timeFrame: Cycle 2 through Cycle 6 or 8 (end of study)
measure: Duration of Rituximab Infusion Including Dose Interruption Times
timeFrame: Day 1 of each of Cycles 1 to 6 or 8
measure: Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)
timeFrame: Day 1 of Cycles 2 and either 6 or 8 (last cycle)
measure: Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)
timeFrame: Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Deborah Hurst, M.D.
role: STUDY_DIRECTOR
References: