Conditions: Non-Hodgkin's Lymphoma
Keywords: Follicular NHL NHL Large B-Cell NHL
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 451
Healthy volunteers: no

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).

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: Rituximab intervention 2: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) intervention 3: CVP (cyclophosphamide, vincristine, prednisone) intervention 4: Analgesic/antipyretic and antihistamine drugs
Intervention descriptions: intervention 1: 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. intervention 2: Commercial preparations of CHOP were used. Prednisone was administered prior to rituximab infusion. intervention 3: Commercial preparations of CVP were used. Prednisone was administered prior to rituximab infusion. intervention 4: An analgesic/antipyretic (eg, acetaminophen) and an antihistamine (eg, diphenhydramine) were administered 30 minutes before each infusion of rituximab.

Protocol document: