Trial · NCT02536664
Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
NCT02536664, Completed, Hoffmann-La Roche; results first posted 2015-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants. Trials, record NCT02536664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02536664
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
- NCT number
- NCT02536664
- Status
- Completed
- Enrollment
- 505 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Follicular Lymphoma
- Interventions
- Rituximab
- First posted
- 2015-09-01
- Last updated
- 2023-04-18
- Results first posted
- 2015-11-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Were Alive and Free From Progressive Disease | 2 years | Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. |
| Secondary | Median Progression Free Survival (PFS) Time | 2 years | PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate. |
| Secondary | Percentage of Participants Who Were Alive | 2 years | Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported. |
| Secondary | Median Overall Survival (OS) Time | 2 years | Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate. |
| Secondary | Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy | 2 years | CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. |
| Secondary | Percentage of Participants With Best Overall Response | 2 years | The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. |
| Secondary | Percentage of Participants With Initiation of New Therapy | 2 years | Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Were Alive and Free From Progressive Disease | 2 years | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | percentage of participants | NUMBER |
| SECONDARY | Median Progression Free Survival (PFS) Time | 2 years | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Were Alive | 2 years | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | percentage of participants | NUMBER |
| SECONDARY | Median Overall Survival (OS) Time | 2 years | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy | 2 years | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response | 2 years | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Initiation of New Therapy | 2 years | Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Were Alive and Free From Progressive Disease | First-line Stratum | 88.28 | 95% Confidence Interval 83.97 to 92.59 | percentage of participants | |
| Percentage of Participants Who Were Alive and Free From Progressive Disease | Relapsed/Refractory Stratum | 76.03 | 95% Confidence Interval 68.79 to 83.28 | percentage of participants | |
| Median Progression Free Survival (PFS) Time | First-line Stratum | NA | 95% Confidence Interval NA to NA | months | |
| Median Progression Free Survival (PFS) Time | Relapsed/Refractory Stratum | NA | 95% Confidence Interval NA to NA | months | |
| Percentage of Participants Who Were Alive | First-line Stratum | 96.89 | 95% Confidence Interval 94.69 to 99.09 | percentage of participants | |
| Percentage of Participants Who Were Alive | Relapsed/Refractory Stratum | 95.44 | 95% Confidence Interval 91.81 to 99.07 | percentage of participants | |
| Median Overall Survival (OS) Time | First-line Stratum | NA | 95% Confidence Interval NA to NA | months | |
| Median Overall Survival (OS) Time | Relapsed/Refractory Stratum | NA | 95% Confidence Interval NA to NA | months | |
| Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy | First-line Stratum | CR | 58.4 | percentage of participants | |
| Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy | Relapsed/Refractory Stratum | CR | 51.2 | percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | First-line Stratum | 312 | |
| Overall Study | STARTED | Relapsed/Refractory Stratum | 177 | |
| Overall Study | COMPLETED | First-line Stratum | 205 | |
| Overall Study | COMPLETED | Relapsed/Refractory Stratum | 97 | |
| Overall Study | NOT COMPLETED | First-line Stratum | 107 | |
| Overall Study | NOT COMPLETED | Relapsed/Refractory Stratum | 80 |
Source ClinicalTrials.gov
Adverse events204
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 | Leukopenia | Blood and lymphatic system disorders | First-line Stratum | 0 | 310 | |
| other | Leukopenia | Blood and lymphatic system disorders | Relapsed/Refractory Stratum | 21 | 173 | |
| other | Bacterial Infection | Infections and infestations | First-line Stratum | 0 | 310 | |
| other | Bacterial Infection | Infections and infestations | Relapsed/Refractory Stratum | 14 | 173 | |
| serious | Agranulocytosis | Blood and lymphatic system disorders | First-line Stratum | 1 | 312 | |
| serious | Agranulocytosis | Blood and lymphatic system disorders | Relapsed/Refractory Stratum | 0 | 177 | |
| serious | Leukopenia | Blood and lymphatic system disorders | First-line Stratum | 5 | 312 | |
| serious | Leukopenia | Blood and lymphatic system disorders | Relapsed/Refractory Stratum | 8 | 177 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | First-line Stratum | 1 | 312 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Relapsed/Refractory Stratum | 2 | 177 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | First-line Stratum | ||
| Total, all-cause mortality | Relapsed/Refractory Stratum | ||
| Total, other adverse events | First-line Stratum | 0 | 310 |
| Total, other adverse events | Relapsed/Refractory Stratum | 30 | 173 |
| Total, serious adverse events | First-line Stratum | 35 | 312 |
| Total, serious adverse events | Relapsed/Refractory Stratum | 39 | 177 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| First-line Stratum vs Relapsed/Refractory Stratum: serious adverse events |
Source 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.
GET https://conductscience.org/api/trials/v1/NCT02536664
GET https://conductscience.org/api/trials/v1/NCT02536664/results?page=2