Trial · NCT00075946
Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
NCT00075946, Phase 3, Completed, Eastern Cooperative Oncology Group; results first posted 2015-06-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma. Trials, record NCT00075946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00075946
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
- NCT number
- NCT00075946
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 545 participants, actual
- Lead sponsor
- Eastern Cooperative Oncology Group
- Conditions
- Lymphoma
- Interventions
- rituximab
- First posted
- 2004-01-14
- Last updated
- 2024-02-01
- Results first posted
- 2015-06-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Rituximab Failure (TTRF) | Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first. | TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression \< 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death). |
| Secondary | Time to First Cytotoxic Therapy (TTFC) | Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first. | TTFC is defined as the time from randomization to the time of first cytotoxic therapy (chemo and radio therapy), and censored as last follow-up time if no cytotoxic therapy has been used. Since median TTFC was not reached in 3 out of the 4 groups, 3-year TTFC was reported which was defined as the probability of not starting first cytotoxic therapy at 3 years. |
| Secondary | Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization | Assessed at baseline and 6 months after randomization. | The overall HRQL was measured by the change in Functional Assessment of Cancer Therapy - General (FACT-G) from baseline to 6 months after randomization. The FACT-G is a 27-item assessment used to measure HRQL, specifically, physical, functional, social and emotional well-being. The total score ranges from 0 to 108, with higher scores indicating better HRQL. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Rituximab Failure (TTRF) | Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first. | Eligible patients who were randomized to one of the two arms for maintenance therapy. | years | MEDIAN |
| SECONDARY | Time to First Cytotoxic Therapy (TTFC) | Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first. | Patients who were correctly randomized to one of the two maintenance arms. | probability | NUMBER |
| SECONDARY | Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization | Assessed at baseline and 6 months after randomization. | Patients with patient-reported outcomes (PRO) data available. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Rituximab Failure (TTRF) | Rituximab Retreatment: Follicular Patients | 3.92 | 95% Confidence Interval 3.09 to 4.93 | years | |
| Time to Rituximab Failure (TTRF) | Rituximab Scheduled: Follicular Patients | 4.32 | 95% Confidence Interval 3.53 to 4.98 | years | |
| Time to Rituximab Failure (TTRF) | Rituximab Retreatment: Non-Follicular Patients | 1.39 | 95% Confidence Interval 1.07 to NA | years | |
| Time to Rituximab Failure (TTRF) | Rituximab Scheduled: Non-Follicular Patients | 4.83 | 95% Confidence Interval 2.46 to NA | years | |
| Time to First Cytotoxic Therapy (TTFC) | Rituximab Retreatment: Follicular Patients | 0.84 | 95% Confidence Interval 0.78 to 0.90 | probability | |
| Time to First Cytotoxic Therapy (TTFC) | Rituximab Scheduled: Follicular Patients | 0.95 | 95% Confidence Interval 0.91 to 0.99 | probability | |
| Time to First Cytotoxic Therapy (TTFC) | Rituximab Retreatment: Non-Follicular Patients | 0.72 | 95% Confidence Interval 0.55 to 0.94 | probability | |
| Time to First Cytotoxic Therapy (TTFC) | Rituximab Scheduled: Non-Follicular Patients | 1 | 95% Confidence Interval 1 to 1 | probability | |
| Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization | Arm A: Rituximab Retreatment | 1.04 | Standard Deviation 12.82 | units on a scale | |
| Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization | Arm B: Rituximab Scheduled | -0.71 | Standard Deviation 9.38 | units on a scale |
Source ClinicalTrials.gov
Participant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab Retreatment: Follicular Patients | 148 | |
| Overall Study | STARTED | Rituximab Scheduled: Follicular Patients | 151 | |
| Overall Study | STARTED | Rituximab Retreatment: Non-Follicular Patients | 28 | |
| Overall Study | STARTED | Rituximab Scheduled: Non-Follicular Patients | 30 | |
| Overall Study | STARTED | Enrolled But Not Randomized | 188 | |
| Overall Study | Treated and With Toxicity Data Available | Rituximab Retreatment: Follicular Patients | 142 | |
| Overall Study | Treated and With Toxicity Data Available | Rituximab Scheduled: Follicular Patients | 148 | |
| Overall Study | Treated and With Toxicity Data Available | Rituximab Retreatment: Non-Follicular Patients | 27 | |
| Overall Study | Treated and With Toxicity Data Available | Rituximab Scheduled: Non-Follicular Patients | 29 | |
| Overall Study | Treated and With Toxicity Data Available | Enrolled But Not Randomized | 154 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events87
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 | Fatigue | General disorders | Arm I: Induction Rituximab | 36 | 500 | |
| other | Fatigue | General disorders | Arm A: Rituximab Retreatment | 5 | 169 | |
| other | Fatigue | General disorders | Arm B: Rituximab Scheduled | 14 | 177 | |
| serious | Anaphylaxis | Immune system disorders | Arm I: Induction Rituximab | 2 | 500 | |
| serious | Anaphylaxis | Immune system disorders | Arm A: Rituximab Retreatment | 0 | 169 | |
| serious | Anaphylaxis | Immune system disorders | Arm B: Rituximab Scheduled | 0 | 177 | |
| serious | Hearing impaired | Ear and labyrinth disorders | Arm I: Induction Rituximab | 0 | 500 | |
| serious | Hearing impaired | Ear and labyrinth disorders | Arm A: Rituximab Retreatment | 0 | 169 | |
| serious | Hearing impaired | Ear and labyrinth disorders | Arm B: Rituximab Scheduled | 1 | 177 | |
| serious | Lymphocyte count decreased | Investigations | Arm I: Induction Rituximab | 0 | 500 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Induction Rituximab | ||
| Total, all-cause mortality | Arm A: Rituximab Retreatment | ||
| Total, all-cause mortality | Arm B: Rituximab Scheduled | ||
| Total, other adverse events | Arm I: Induction Rituximab | 36 | 500 |
| Total, other adverse events | Arm A: Rituximab Retreatment | 5 | 169 |
| Total, other adverse events | Arm B: Rituximab Scheduled | 14 | 177 |
| Total, serious adverse events | Arm I: Induction Rituximab | 23 | 500 |
| Total, serious adverse events | Arm A: Rituximab Retreatment | 5 | 169 |
| Total, serious adverse events | Arm B: Rituximab Scheduled | 10 | 177 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
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/NCT00075946
GET https://conductscience.org/api/trials/v1/NCT00075946/flow?page=2