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
18 Years
N/A
Both
Non-Hodgkin's Lymphoma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome 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
Outcome Description:
The percentage of patients who developed Grade 3 or 4 IRRs resulting from faster infusion of rituximab at Cycle 2 was assessed in patients who had previously received rituximab at the standard infusion rate without experiencing a Grade 3 or 4 IRR at Cycle 1. IRRs were a predefined list of Medical Dictionary for Regulatory Activities (MedDRA) terms for infusion-related adverse events occurring on the day of and/or the day after rituximab infusion. The list of IRR terms was compiled based on IRRs observed in the present and previous studies in which rituximab was infused at the standard rate.
Outcome Time Frame:
Days 1 and 2 of Cycle 2
Safety Issue:
Yes
Principal Investigator
Deborah Hurst, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Genentech
Authority:
United States: Food and Drug Administration
Study ID:
U4391g
NCT ID:
NCT00719472
Start Date:
July 2008
Completion Date:
May 2011
Related Keywords:
- Non-Hodgkin's Lymphoma
- Follicular NHL
- NHL
- Large B-Cell NHL
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
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