Trial · NCT01732913
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
NCT01732913, Phase 3, Terminated, Gilead Sciences; results first posted 2017-05-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas. Trials, record NCT01732913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01732913
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
- NCT number
- NCT01732913
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 295 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Indolent Non-Hodgkin's Lymphomas
- Interventions
- Placebo, Rituximab, Idelalisib
- First posted
- 2012-11-26
- Last updated
- 2018-11-16
- Results first posted
- 2017-05-11
- Limitations and caveats
- Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC). | |
| Secondary | Overall Response Rate | Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC. | |
| Secondary | Lymph Node Response Rate | Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC. | |
| Secondary | Complete Response Rate | Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC. | |
| Secondary | Overall Survival | Overall survival is defined as the interval from randomization to death from any cause. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted. | |||
| SECONDARY | Overall Response Rate | Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted. | |||
| SECONDARY | Lymph Node Response Rate | Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted. | |||
| SECONDARY | Complete Response Rate | Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted. | |||
| SECONDARY | Overall Survival | Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Idelalisib + Rituximab | 198 | |
| Overall Study | STARTED | Placebo + Rituximab | 97 | |
| Overall Study | COMPLETED | Idelalisib + Rituximab | 42 | |
| Overall Study | COMPLETED | Placebo + Rituximab | 28 | |
| Overall Study | NOT COMPLETED | Idelalisib + Rituximab | 156 | |
| Overall Study | NOT COMPLETED | Placebo + Rituximab | 69 |
Source ClinicalTrials.gov
Adverse events300
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 | Anaemia | Blood and lymphatic system disorders | Idelalisib + Rituximab | 12 | 198 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Rituximab | 6 | 95 | |
| other | Neutropenia | Blood and lymphatic system disorders | Idelalisib + Rituximab | 25 | 198 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Rituximab | 5 | 95 | |
| other | Abdominal pain | Gastrointestinal disorders | Idelalisib + Rituximab | 20 | 198 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo + Rituximab | 4 | 95 | |
| other | Constipation | Gastrointestinal disorders | Idelalisib + Rituximab | 28 | 198 | |
| other | Constipation | Gastrointestinal disorders | Placebo + Rituximab | 13 | 95 | |
| other | Diarrhoea | Gastrointestinal disorders | Idelalisib + Rituximab | 88 | 198 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Rituximab | 18 | 95 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Idelalisib + Rituximab | ||
| Total, all-cause mortality | Placebo + Rituximab | ||
| Total, other adverse events | Idelalisib + Rituximab | 189 | 198 |
| Total, other adverse events | Placebo + Rituximab | 83 | 95 |
| Total, serious adverse events | Idelalisib + Rituximab | 103 | 198 |
| Total, serious adverse events | Placebo + Rituximab | 11 | 95 |
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 |
|---|
| Idelalisib + Rituximab vs Placebo + Rituximab: 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/NCT01732913
GET https://conductscience.org/api/trials/v1/NCT01732913/events?page=2