Trial · NCT01461928
A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab
NCT01461928, Phase 3, Completed, Hoffmann-La Roche; results first posted 2019-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab. Trials, record NCT01461928. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01461928
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab
- NCT number
- NCT01461928
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 692 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Chemotherapy (Induction Period), Rituximab
- First posted
- 2011-10-28
- Last updated
- 2019-08-06
- Other registries' IDs
- eudract:2010-023407-95
- Results first posted
- 2019-08-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months) | Progression free survival from randomization (PFSrand) is defined as the time from date of randomization to the date of first documented disease progression or death, whichever occurs first. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed. The Observation arm did not include one participant with AE outcome of death reported retrospectively 2 months after discontinuation from study (censored as having no event on Day 456 post-randomization). |
| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs) | From day of first rituximab induction dose up to day of disease progression, or discontinuation of treatment for any reason (up to approximately 87 months) | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 (obtained retrospectively) were collected for this arm. Therefore arms are not comparable overall. |
| Secondary | Event-free Survival (Time to Treatment Failure) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From day of first rituximab induction dose up to day of any treatment failure, including disease progression, or discontinuation of treatment for any reason (up to approximately 87 months) | Event-Free Survival was measured from the day of first rituximab Induction dose through Maintenance I and Maintenance II rituximab arm until the date of any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g. disease progression, toxicity, patient preference, initiation of new anti-lymphoma treatment, or death). Treatment discontinuation was considered as an event and was not applicable to the randomized observation arm. |
| Secondary | Time to Next Lymphoma Treatment (TNLT) | From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months) | Time to next lymphoma treatment (TNLT) is defined as the time from date of first rituximab induction dose to the date date of first documented intake of any new antilymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc.). |
| Secondary | Overall Survival | From day of first rituximab induction dose up to death (up to approximately 87 months) | Overall survival from first induction treatment (OSRegist) is defined as the time from date of first rituximab induction dose to the date of death, irrespective of cause. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed. |
| Secondary | Maintenance II: Overall Survival | From randomization (Maintenance II) up to death (up to approximately 24 months) | Overall survival from randomization (OSrand) is defined as the time from date of randomization to the date of death, irrespective of cause. |
| Secondary | Percentage of Participants With Partial or Complete Tumor Response (PR/CR) Assessment at End of Induction Using 1999 International Working Group Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From day of first rituximab induction dose up to end of induction period (up to approximately 8 months) | Overall response rate is defined as the proportion of responders at the end of the Induction period. A responder is defined as a participant experiencing either CR or PR tumor response according to the Cheson response criteria for indolent lymphoma or the recommendations for Waldenström's macroglobulinemia. |
| Secondary | Maintenance I: Percentage of Participants With Conversion of PR to CR Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From day of first rituximab induction dose up to end of Maintenance I period (up to approximately 32 months) | |
| Secondary | Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From day of first rituximab induction dose up to disease progression or death, whichever occurs first (up to approximately 87 months) | Progression free survival from first induction treatment (PFSregist) is defined as the time from date of first rituximab induction dose to the date of first documented disease progression or death by any cause, whichever occurs first. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months) | The primary efficacy analysis population was the ITT population (ITTrand), which included only randomised participants (Maintenance II only) and was used for the analysis of the primary efficacy endpoint of PFS and the secondary analysis endpoint overall survival (OS). The PFS end point was not reached. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs) | From day of first rituximab induction dose up to day of disease progression, or discontinuation of treatment for any reason (up to approximately 87 months) | The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization. | Participants | NUMBER |
| SECONDARY | Event-free Survival (Time to Treatment Failure) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From day of first rituximab induction dose up to day of any treatment failure, including disease progression, or discontinuation of treatment for any reason (up to approximately 87 months) | All participants who were enrolled into the given study period and had received at least one dose of study treatment at any time were included in the ITT population for each period of the study; Induction, Maintenance I and Maintenance I | Months | MEDIAN |
| SECONDARY | Time to Next Lymphoma Treatment (TNLT) | From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months) | The analysis population was the randomised ITT population (ITTrand), which included only randomised participants (Maintenance II only) as well as the ITT population, that included all participants who had completed a Baseline visit and at least one on-treatment assessment (Induction, Maintenance I and Maintenance II). | Months | MEDIAN |
| SECONDARY | Overall Survival | From day of first rituximab induction dose up to death (up to approximately 87 months) | The ITT population included all participants who had completed a Baseline visit and at least one on-treatment assessment and were enrolled into each period of the study; Induction, Maintenance I and Maintenance II. | Months | MEDIAN |
| SECONDARY | Maintenance II: Overall Survival | From randomization (Maintenance II) up to death (up to approximately 24 months) | The analysis population was the randomised ITT population (ITTrand), which included only randomised participants (Maintenance II only) and was used for the analysis of the primary efficacy endpoint of PFS and the secondary analysis endpoint overall survival (OS). | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Partial or Complete Tumor Response (PR/CR) Assessment at End of Induction Using 1999 International Working Group Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From day of first rituximab induction dose up to end of induction period (up to approximately 8 months) | The ITT population included all participants who had completed a Baseline visit and at least one on-treatment assessment and were enrolled into each period of the study; Induction, Maintenance I and Maintenance II. | Percentage of Participants | NUMBER |
| SECONDARY | Maintenance I: Percentage of Participants With Conversion of PR to CR Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From day of first rituximab induction dose up to end of Maintenance I period (up to approximately 32 months) | The Maintenance I participant analysis group consisted of a subgroup of responding participants who completed Induction and successfully enrolled into Maintenance I. Participants who had partial response (PR) at the end of Induction were included in this analysis. | Percentage | NUMBER |
| SECONDARY | Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | From day of first rituximab induction dose up to disease progression or death, whichever occurs first (up to approximately 87 months) | The ITT population included all participants who had completed a Baseline visit and at least one on-treatment assessment and were enrolled into each period of the study; Induction, Maintenance I and Maintenance II. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | Maintenance II - Arm A (Rituximab) | NA | 95% Confidence Interval NA to NA | Months | |
| Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | Maintenance II - Arm B (Observation Only) | NA | 95% Confidence Interval 39.75 to NA | Months | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs) | All Participants | Number of Participants with Adverse Events | 643 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs) | All Participants | Number of Participants with Serious Adverse Events | 339 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs) | All Participants | Number of Participants with IRRs/ARRs | 330 | Participants | |
| Event-free Survival (Time to Treatment Failure) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | Maintenance II - Arm A (Rituximab) | 65.38 | 95% Confidence Interval 60.98 to NA | Months | |
| Event-free Survival (Time to Treatment Failure) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia | All Participants | 24.99 | 95% Confidence Interval 20.73 to 27.99 | Months | |
| Time to Next Lymphoma Treatment (TNLT) | Maintenance II - Arm A (Rituximab) | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Next Lymphoma Treatment (TNLT) | Maintenance II - Arm B (Observation Only) | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Next Lymphoma Treatment (TNLT) | All Participants | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction (up to 8 Months) | STARTED | All Participants | 692 | |
| Induction (up to 8 Months) | STARTED | Maintenance II - Arm A (Rituximab) | 0 | |
| Induction (up to 8 Months) | STARTED | Maintenance II - Arm B (Observation Only) | 0 | |
| Induction (up to 8 Months) | COMPLETED | All Participants | 494 | |
| Induction (up to 8 Months) | COMPLETED | Maintenance II - Arm A (Rituximab) | 0 | |
| Induction (up to 8 Months) | COMPLETED | Maintenance II - Arm B (Observation Only) | 0 | |
| Induction (up to 8 Months) | NOT COMPLETED | All Participants | 198 | |
| Induction (up to 8 Months) | NOT COMPLETED | Maintenance II - Arm A (Rituximab) | 0 | |
| Induction (up to 8 Months) | NOT COMPLETED | Maintenance II - Arm B (Observation Only) | 0 | |
| Maintenance I (24 Months) | STARTED | All Participants | 494 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events3,540
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 | Venous thrombosis limb | Vascular disorders | Arm A | 1 | 138 | 1 |
| other | Venous thrombosis limb | Vascular disorders | Arm B (Observation Only) | 0 | 138 | 0 |
| other | Venous thrombosis limb | Vascular disorders | All Participants | 1 | 692 | 1 |
| other | Venous thrombosis | Vascular disorders | Arm A | 0 | 138 | 0 |
| other | Venous thrombosis | Vascular disorders | Arm B (Observation Only) | 0 | 138 | 0 |
| other | Venous thrombosis | Vascular disorders | All Participants | 1 | 692 | 1 |
| other | Varicose vein | Vascular disorders | Arm A | 1 | 138 | 1 |
| other | Varicose vein | Vascular disorders | Arm B (Observation Only) | 1 | 138 | 1 |
| other | Varicose vein | Vascular disorders | All Participants | 4 | 692 | 4 |
| other | Varicose ulceration | Vascular disorders | Arm A | 0 | 138 | 0 |
1 to 10 of 3,540Source ClinicalTrials.gov
See all 3,540 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 10 | 138 |
| Total, all-cause mortality | Arm B (Observation Only) | 8 | 138 |
| Total, all-cause mortality | All Participants | 161 | 692 |
| Total, other adverse events | Arm A | 133 | 138 |
| Total, other adverse events | Arm B (Observation Only) | 133 | 138 |
| Total, other adverse events | All Participants | 643 | 692 |
| Total, serious adverse events | Arm A | 59 | 138 |
| Total, serious adverse events | Arm B (Observation Only) | 58 | 138 |
| Total, serious adverse events | All Participants | 339 | 692 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01461928
GET https://conductscience.org/api/trials/v1/NCT01461928/flow?page=2