A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE)
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Intervention: Rituximab; CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone); CVP (cyclophosphamide, vincristine, prednisone); Analgesic/antipyretic and antihistamine drugs
Intervention description: During Cycle 1 rituximab was administered at an initial rate of 50 mg/hour. In the absence of infusion toxicity during Cycle 1, the infusion rate was escalated by 50 mg/h increments every 30 minutes to a maximum rate of 400 mg/hour. In case of infusion-related reactions, the infusion was interrupted or the infusion rate reduced. In case of Grade 3/4 infusion reactions, the rituximab infusion was discontinued and medical treatment provided. If the rituximab infusion in Cycle 1 was tolerated without a serious adverse event (AE) or Grade 3/4 infusion-related AE, as judged by the investigator, infusions in Cycle 2 onwards were administered as follows: 20% of the total dose was given over 30 minutes and the remaining 80% of the dose was given over the next 60 minutes, for a total infusion time of 90 minutes. Commercial preparations of rituximab were used.; Commercial preparations of CHOP were used. Prednisone was administered prior to rituximab infusion.; Commercial preparations of CVP were used. Prednisone was administered prior to rituximab infusion.; An analgesic/antipyretic (eg, acetaminophen) and an antihistamine (eg, diphenhydramine) were administered 30 minutes before each infusion of rituximab.
Intervention MeSH terms: Antipyretics; Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Analgesics; Histamine Antagonists; Histamine H1 Antagonists
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Follicular NHL; NHL; Large B-Cell NHL

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