TriangleNCT00719472 · CITED IN SOURCE DOCUMENTS
A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2017-05-15
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).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
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
Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1
Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)
Duration of Rituximab Infusion Including Dose Interruption Times
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)
Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- 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.
- intervention Names
- Drug: Rituximab
- Drug: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)
- Drug: CVP (cyclophosphamide, vincristine, prednisone)
- Drug: Analgesic/antipyretic and antihistamine drugs
- label
- Rituximab 375 mg/m^2
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Rituximab 375 mg/m^2
- 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.
- name
- Rituximab
- type
- DRUG
- arm Group Labels
- Rituximab 375 mg/m^2
- description
- Commercial preparations of CHOP were used. Prednisone was administered prior to rituximab infusion.
- name
- CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)
- type
- DRUG
- arm Group Labels
- Rituximab 375 mg/m^2
- description
- Commercial preparations of CVP were used. Prednisone was administered prior to rituximab infusion.
- name
- CVP (cyclophosphamide, vincristine, prednisone)
- type
- DRUG
- arm Group Labels
- Rituximab 375 mg/m^2
- description
- An analgesic/antipyretic (eg, acetaminophen) and an antihistamine (eg, diphenhydramine) were administered 30 minutes before each infusion of rituximab.
- name
- Analgesic/antipyretic and antihistamine drugs
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 451
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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.
- 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
- time Frame
- Days 1 and 2 of Cycle 2
- secondary Outcomes
- measure
- Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1
- time Frame
- Cycle 1
- measure
- Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)
- time Frame
- Cycle 2 through Cycle 6 or 8 (end of study)
- description
- The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported.
- measure
- Duration of Rituximab Infusion Including Dose Interruption Times
- time Frame
- Day 1 of each of Cycles 1 to 6 or 8
- description
- Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples.
- measure
- 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)
- time Frame
- Day 1 of Cycles 2 and either 6 or 8 (last cycle)
- description
- Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS).
- measure
- Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)
- time Frame
- Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)
Full study description
- 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).
Source references
Source notices and limitations
Discovery and provenance
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- exact text
- NCT00719472
- start
- 7564
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00400.json
- source file sha256
- a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
- source json pointer
- /results/83/use_in_specific_populations/0
- source kind
- fda_spl_label
- source record id
- 7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- e5e95ff93b2940d57955af9c87e660aa17696cc5c32f736b3dc9bb92f0046de5
- spl effective time
- 20260722
- spl set id
- da1c4de7-0e5b-4f72-97ec-7a8d368f085f
Preserved source evidence · Not medical advice