Trial · NCT01649856
A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
NCT01649856, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma. Trials, record NCT01649856. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01649856
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
- NCT number
- NCT01649856
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 572 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Interventions
- CHOP, rituximab [MabThera/Rituxan], rituximab [MabThera/Rituxan]
- First posted
- 2012-07-25
- Last updated
- 2017-10-11
- Other registries' IDs
- eudract:2012-000669-19
- Results first posted
- 2016-02-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) | Up to approximately 4.25 years | Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (\>) 75 percent (%) but still \>1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI). |
| Secondary | Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | At Cycle 7 (each cycle was 14 or 21 days) | The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. |
| Secondary | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | At Cycle 7 (each cycle was 14 or 21 days) | The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. |
| Secondary | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days) | Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported. |
| Secondary | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days) | Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as "Missing". |
| Secondary | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days) | Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as "Missing". |
| Secondary | Number of Participants With an Event-Free Survival (EFS) Event | Up to approximately 4.25 years | EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. |
| Secondary | Duration of EFS | Up to approximately 4.25 years | EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. |
| Secondary | Number of Participants With Relapse or Death at the Time of Primary Analysis | Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination) | Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined. |
| Secondary | Duration of Disease-Free Survival (DFS) | Up to approximately 4.25 years | DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node \>1 cm, following an earlier assessment of CR or CRu. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) | Up to approximately 4.25 years | Intent-to-Treat (ITT) Population: All participants who completed Baseline and at least one on-treatment efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | At Cycle 7 (each cycle was 14 or 21 days) | ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain. | units on a scale | MEAN |
| SECONDARY | Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | At Cycle 7 (each cycle was 14 or 21 days) | ITT Population (RASQ Subpopulation): All participants who completed the RASQ at Cycles 3 and 7; n = number of participants in the analysis for the specified domain. | units on a scale | MEAN |
| SECONDARY | Median Duration of Rituximab Administration for Each Treatment Cycle | Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days) | Safety Population; n = number of participants in the analysis for the specified timepoint. | hours | MEDIAN |
| SECONDARY | Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle | Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days) | Safety Population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle | Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days) | Safety Population. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With an Event-Free Survival (EFS) Event | Up to approximately 4.25 years | ITT Population. | participants | NUMBER |
| SECONDARY | Duration of EFS | Up to approximately 4.25 years | ITT Population. | months | MEDIAN |
| SECONDARY | Number of Participants With Relapse or Death at the Time of Primary Analysis | Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination) | ITT Population (Responder Subpopulation): All participants who achieved CR or CRu after 4 cycles. | participants | NUMBER |
| SECONDARY | Duration of Disease-Free Survival (DFS) | Up to approximately 4.25 years | ITT Population (Responder Subpopulation). | months | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group276
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) | Rituximab SC | 50.6 | 95% Confidence Interval 45.2 to 56.0 | percentage of participants | |
| Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) | Rituximab IV | 42.4 | 95% Confidence Interval 35.0 to 50.0 | percentage of participants | |
| Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Rituximab SC | Expectations of Therapy (n=280,141) | 79.35 | Standard Deviation 17.422 | units on a scale |
| Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Rituximab IV | Expectations of Therapy (n=280,141) | 82.94 | Standard Deviation 16.536 | units on a scale |
| Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Rituximab SC | Feelings about Side Effects (n=276,141) | 60.69 | Standard Deviation 21.594 | units on a scale |
| Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Rituximab IV | Feelings about Side Effects (n=276,141) | 57.62 | Standard Deviation 23.339 | units on a scale |
| Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Rituximab SC | Satisfaction with Therapy (n=278,141) | 85.92 | Standard Deviation 11.428 | units on a scale |
| Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores | Rituximab IV | Satisfaction with Therapy (n=278,141) | 83.60 | Standard Deviation 13.451 | units on a scale |
| Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Rituximab SC | Physical Impact (n=278,140) | 86.24 | Standard Deviation 14.012 | units on a scale |
| Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores | Rituximab IV | Physical Impact (n=278,140) | 81.49 | Standard Deviation 16.848 | units on a scale |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab Subcutaneous (SC) | 369 | |
| Overall Study | STARTED | Rituximab Intravenous (IV) | 203 | |
| Overall Study | COMPLETED | Rituximab Subcutaneous (SC) | 230 | |
| Overall Study | COMPLETED | Rituximab Intravenous (IV) | 125 | |
| Overall Study | NOT COMPLETED | Rituximab Subcutaneous (SC) | 139 | |
| Overall Study | NOT COMPLETED | Rituximab Intravenous (IV) | 78 |
Source ClinicalTrials.gov
Adverse events404
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 SC | 104 | 369 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab IV | 54 | 203 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab SC | 88 | 369 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab IV | 40 | 203 | |
| other | Nausea | Gastrointestinal disorders | Rituximab SC | 79 | 369 | |
| other | Nausea | Gastrointestinal disorders | Rituximab IV | 47 | 203 | |
| other | Constipation | Gastrointestinal disorders | Rituximab SC | 56 | 369 | |
| other | Constipation | Gastrointestinal disorders | Rituximab IV | 34 | 203 | |
| other | Diarrhoea | Gastrointestinal disorders | Rituximab SC | 52 | 369 | |
| other | Diarrhoea | Gastrointestinal disorders | Rituximab IV | 20 | 203 |
1 to 10 of 404Source ClinicalTrials.gov
See all 404 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab SC | ||
| Total, all-cause mortality | Rituximab IV | ||
| Total, other adverse events | Rituximab SC | 319 | 369 |
| Total, other adverse events | Rituximab IV | 172 | 203 |
| Total, serious adverse events | Rituximab SC | 155 | 369 |
| Total, serious adverse events | Rituximab IV | 77 | 203 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28935843 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rituximab SC vs Rituximab IV: Number of Participants With an Event-Free Survival (EFS) Event | Trial comparisons |
| Rituximab SC vs Rituximab IV: Number of Participants With Progression, Relapse, or Death | Trial comparisons |
| Rituximab SC vs Rituximab IV: Number of Participants With Relapse or Death at the Time of Primary Analysis | Trial comparisons |
| Rituximab SC vs Rituximab IV: Number of Deaths | Trial comparisons |
| Rituximab SC vs Rituximab IV: serious adverse events | Trial comparisons |
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.
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