Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CVP · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Rituximab 375 mg/m^2 | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Rituximab | DRUG | 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. |
| CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) | DRUG | Commercial preparations of CHOP were used. Prednisone was administered prior to rituximab infusion. |
| CVP (cyclophosphamide, vincristine, prednisone) | DRUG | Commercial preparations of CVP were used. Prednisone was administered prior to rituximab infusion. |
| Analgesic/antipyretic and antihistamine drugs | DRUG | An analgesic/antipyretic (eg, acetaminophen) and an antihistamine (eg, diphenhydramine) were administered 30 minutes before each infusion of rituximab. |
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 \[vincris...
CVP is a small molecule oncology drug being studied for the treatment of Non-Hodgkin's Lymphoma. It is currently in Phase 3 clinical development as an investigational therapy. The drug has completed one Phase 3 trial with 451 participants, though it remains in clinical development and is not yet approved.
CVP is being developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. Roche is conducting clinical research on this investigational oncology drug for Non-Hodgkin's Lymphoma. The drug is currently in Phase 3 development.
CVP is in Phase 3 clinical development for Non-Hodgkin's Lymphoma. It has completed one Phase 3 trial, NCT00719472, which enrolled 451 participants. The drug is investigational and has not been approved, as it remains in active clinical development.
CVP has been studied in one completed Phase 3 clinical trial, NCT00719472, titled 'A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE)'. The trial enrolled 451 participants aged 18 years and older with Non-Hodgkin's Lymphoma.
CVP is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Non-Hodgkin's Lymphoma. The drug has completed one Phase 3 trial, but it remains under clinical investigation and has not received regulatory approval.