Clinical trial · Interventional

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

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

NCT00719472CI-TRIAL-00027561RATEcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non-Hodgkin's Lymphoma	Non-Hodgkin Lymphoma	ALIAS	0.90

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Analgesic/antipyretic and antihistamine drugs	Drug	—	UNRESOLVED
CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)	Drug	—	UNRESOLVED
CVP (cyclophosphamide, vincristine, prednisone)	Drug	—	UNRESOLVED
Rituximab	Drug	Rituximab	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Rituximab 375 mg/m^2
description
Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
interventionNames
1. Drug: Rituximab
2. Drug: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)
3. Drug: CVP (cyclophosphamide, vincristine, prednisone)
4. Drug: Analgesic/antipyretic and antihistamine drugs

Primary outcomes (1)

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
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.