Phase 3
Completed N=451
A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE)
Source: ClinicalTrials.gov NCT00719472 ↗Enrolled (actual)
451
Serious AEs
25.2%
Results posted
Jun 2012
Primary outcomePrimary: 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 — 1.1 Percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1.1 | — |
| SECONDARY Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1 |
91.8 | — |
| SECONDARY Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study) |
98.6 | — |
| SECONDARY Duration of Rituximab Infusion Including Dose Interruption Times |
245; 91; 91; 91; 91; 91 | — |
| SECONDARY 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) |
228.0; 275.0; 299.0 | — |
| SECONDARY Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle) |
50.5; 68.3; 87.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT00719472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.