Trial · NCT00719472
A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE)
NCT00719472, Phase 3, Completed, Genentech, Inc.; results first posted 2012-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE). Trials, record NCT00719472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00719472
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE)
- NCT number
- NCT00719472
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 451 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Rituximab, CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone), CVP (cyclophosphamide, vincristine, prednisone), Analgesic/antipyretic and antihistamine drugs
- First posted
- 2008-07-21
- Last updated
- 2017-05-15
- Results first posted
- 2012-06-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Days 1 and 2 of Cycle 2 | 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. |
| Secondary | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1 | Cycle 1 | |
| Secondary | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study) | Cycle 2 through Cycle 6 or 8 (end of study) | |
| Secondary | Duration of Rituximab Infusion Including Dose Interruption Times | Day 1 of each of Cycles 1 to 6 or 8 | The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported. |
| Secondary | 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) | Day 1 of Cycles 2 and either 6 or 8 (last cycle) | 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. |
| Secondary | Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle) | Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle) | 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). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Days 1 and 2 of Cycle 2 | Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1 | Cycle 1 | Intent-to-treat (ITT) population: All patients who received at least 1 dose of rituximab regardless of infusion rate. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study) | Cycle 2 through Cycle 6 or 8 (end of study) | Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Rituximab Infusion Including Dose Interruption Times | Day 1 of each of Cycles 1 to 6 or 8 | Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. | Minutes | MEDIAN |
| SECONDARY | 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) | Day 1 of Cycles 2 and either 6 or 8 (last cycle) | Pharmacokinetic evaluable population: All patients who received at least 1 infusion of rituximab and had rituximab concentration data. | µg/mL | MEAN |
| SECONDARY | Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle) | Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle) | Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. Only patients with pre-dose CD19+ lymphocyte counts at each time point were included in the analyses. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Rituximab 375 mg/m^2 | 1.1 | 95% Confidence Interval 0.3 to 2.8 | Percentage of participants | |
| Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1 | Rituximab 375 mg/m^2 | 91.8 | Percentage of participants | ||
| Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study) | Rituximab 375 mg/m^2 | 98.6 | Percentage of participants | ||
| Duration of Rituximab Infusion Including Dose Interruption Times | Rituximab 375 mg/m^2 | Cycle 1 (n=362) | 245 | Inter-Quartile Range 225 to 273 | Minutes |
| Duration of Rituximab Infusion Including Dose Interruption Times | Rituximab 375 mg/m^2 | Cycle 2 (n=363) | 91 | Inter-Quartile Range 90 to 98 | Minutes |
| Duration of Rituximab Infusion Including Dose Interruption Times | Rituximab 375 mg/m^2 | Cycle 3 (n=344) | 91 | Inter-Quartile Range 90 to 98 | Minutes |
| Duration of Rituximab Infusion Including Dose Interruption Times | Rituximab 375 mg/m^2 | Cycle 4 (n=329) | 91 | Inter-Quartile Range 90 to 96 | Minutes |
| Duration of Rituximab Infusion Including Dose Interruption Times | Rituximab 375 mg/m^2 | Cycle 5 (n=312) | 91 | Inter-Quartile Range 90 to 95 | Minutes |
| Duration of Rituximab Infusion Including Dose Interruption Times | Rituximab 375 mg/m^2 | Cycle 6 (n=303) | 91 | Inter-Quartile Range 90 to 96 | Minutes |
| Duration of Rituximab Infusion Including Dose Interruption Times | Rituximab 375 mg/m^2 | Cycle 7 (n=59) | 91 | Inter-Quartile Range 90 to 95 | Minutes |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrolled in Study | STARTED | Rituximab 375 mg/m^2 | 451 | |
| Enrolled in Study | COMPLETED | Rituximab 375 mg/m^2 | 425 | |
| Enrolled in Study | NOT COMPLETED | Rituximab 375 mg/m^2 | 26 | |
| Received Cycle 1 Treatment | STARTED | Rituximab 375 mg/m^2 | 425 | |
| Received Cycle 1 Treatment | COMPLETED | Rituximab 375 mg/m^2 | 372 | |
| Received Cycle 1 Treatment | NOT COMPLETED | Rituximab 375 mg/m^2 | 53 | |
| Received Cycle 2 Treatment | STARTED | Rituximab 375 mg/m^2 | 372 | |
| Received Cycle 2 Treatment | COMPLETED | Rituximab 375 mg/m^2 | 304 | |
| Received Cycle 2 Treatment | NOT COMPLETED | Rituximab 375 mg/m^2 | 68 |
Source ClinicalTrials.gov
Adverse events138
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab 375 mg/m^2 | 135 | 425 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab 375 mg/m^2 | 100 | 425 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab 375 mg/m^2 | 55 | 425 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab 375 mg/m^2 | 31 | 425 | |
| other | Nausea | Gastrointestinal disorders | Rituximab 375 mg/m^2 | 202 | 425 | |
| other | Vomiting | Gastrointestinal disorders | Rituximab 375 mg/m^2 | 69 | 425 | |
| other | Constipation | Gastrointestinal disorders | Rituximab 375 mg/m^2 | 142 | 425 | |
| other | Diarrhoea | Gastrointestinal disorders | Rituximab 375 mg/m^2 | 99 | 425 | |
| other | Abdominal pain | Gastrointestinal disorders | Rituximab 375 mg/m^2 | 43 | 425 | |
| other | Dyspepsia | Gastrointestinal disorders | Rituximab 375 mg/m^2 | 51 | 425 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab 375 mg/m^2 | ||
| Total, other adverse events | Rituximab 375 mg/m^2 | 421 | 425 |
| Total, serious adverse events | Rituximab 375 mg/m^2 | 107 | 425 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00719472
GET https://conductscience.org/api/trials/v1/NCT00719472/events?page=2