Trial · NCT01059630
A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)
NCT01059630, Phase 3, Completed, Genentech, Inc.; results first posted 2016-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN). Trials, record NCT01059630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01059630
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)
- NCT number
- NCT01059630
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 413 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Obinutuzumab, Bendamustine
- First posted
- 2010-02-01
- Last updated
- 2020-01-13
- Other registries' IDs
- eudract:2009-015504-25
- Results first posted
- 2016-11-17
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) | PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (\<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (\>) 1 cm in its short axis. |
| Primary | Progression-Free Survival (PFS) as Assessed by IRC | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) | PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of \<1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node \>1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley. |
| Secondary | Number of Participants With PD or Death as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to 8.5 years overall)) | PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of \<1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node \>1 cm in its short axis. |
| Secondary | PFS as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to 8.5 years overall) | PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of \<1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node \>1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. |
| Secondary | Percentage of Participants With Objective Response as Assessed by IRC | Baseline until PD or death, whichever occurred first (up to approximately 5 years) | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015. |
| Secondary | Percentage of Participants With Objective Response as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. |
| Secondary | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | Baseline until PD or death, whichever occurred first (up to approximately 5 years) | BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease \& disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan \& no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic \& hepatic nodules, involvement of other organs is usually assessable \& no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions (e.g., splenic or hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015. |
| Secondary | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) | BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). |
| Secondary | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) | BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease \& disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan \& no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic \& hepatic nodules, involvement of other organs is usually assessable \& no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015. |
| Secondary | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) | BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) | ITT population. | participants | NUMBER |
| PRIMARY | Progression-Free Survival (PFS) as Assessed by IRC | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) | ITT population. | months | MEDIAN |
| SECONDARY | Number of Participants With PD or Death as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to 8.5 years overall)) | ITT population. | participants | NUMBER |
| SECONDARY | PFS as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to 8.5 years overall) | ITT population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response as Assessed by IRC | Baseline until PD or death, whichever occurred first (up to approximately 5 years) | ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) | ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | Baseline until PD or death, whichever occurred first (up to approximately 5 years) | ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) | ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) | ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) | ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment. | percentage of participants | NUMBER |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group514
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | Bendamustine Alone | 125 | participants | ||
| Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | Obinutuzumab + Bendamustine | 87 | participants | ||
| Progression-Free Survival (PFS) as Assessed by IRC | Bendamustine Alone | 14.1 | 95% Confidence Interval 11.7 to 16.6 | months | |
| Progression-Free Survival (PFS) as Assessed by IRC | Obinutuzumab + Bendamustine | 29.2 | 95% Confidence Interval 20.5 to NA | months | |
| Number of Participants With PD or Death as Assessed by Investigator | Bendamustine Alone | 152 | participants | ||
| Number of Participants With PD or Death as Assessed by Investigator | Obinutuzumab + Bendamustine | 132 | participants | ||
| PFS as Assessed by Investigator | Bendamustine Alone | 14.1 | 95% Confidence Interval 12.6 to 16.2 | months | |
| PFS as Assessed by Investigator | Obinutuzumab + Bendamustine | 25.8 | 95% Confidence Interval 20.1 to 36.5 | months | |
| Percentage of Participants With Objective Response as Assessed by IRC | Bendamustine Alone | 77.5 | 95% Confidence Interval 71.24 to 82.98 | percentage of participants | |
| Percentage of Participants With Objective Response as Assessed by IRC | Obinutuzumab + Bendamustine | 75.5 | 95% Confidence Interval 69.00 to 81.23 | percentage of participants |
1 to 10 of 514Source ClinicalTrials.gov
See all 514 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bendamustine Alone | 209 | |
| Overall Study | STARTED | Obinutuzumab + Bendamustine | 204 | |
| Overall Study | COMPLETED | Bendamustine Alone | 82 | |
| Overall Study | COMPLETED | Obinutuzumab + Bendamustine | 101 | |
| Overall Study | NOT COMPLETED | Bendamustine Alone | 127 | |
| Overall Study | NOT COMPLETED | Obinutuzumab + Bendamustine | 103 |
Source ClinicalTrials.gov
Adverse events382
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 | Bendamustine Alone | 34 | 203 | 41 |
| other | ANAEMIA | Blood and lymphatic system disorders | Obinutuzumab + Bendamustine | 23 | 204 | 36 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Bendamustine Alone | 59 | 203 | 103 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Obinutuzumab + Bendamustine | 74 | 204 | 150 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Bendamustine Alone | 50 | 203 | 101 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Obinutuzumab + Bendamustine | 26 | 204 | 54 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Bendamustine Alone | 11 | 203 | 12 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Obinutuzumab + Bendamustine | 6 | 204 | 6 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Bendamustine Alone | 20 | 203 | 23 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Obinutuzumab + Bendamustine | 16 | 204 | 18 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bendamustine Alone | ||
| Total, all-cause mortality | Obinutuzumab + Bendamustine | ||
| Total, other adverse events | Bendamustine Alone | 194 | 203 |
| Total, other adverse events | Obinutuzumab + Bendamustine | 200 | 204 |
| Total, serious adverse events | Bendamustine Alone | 76 | 203 |
| Total, serious adverse events | Obinutuzumab + Bendamustine | 91 | 204 |
Source ClinicalTrials.gov
Papers4
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bendamustine Alone vs Obinutuzumab + Bendamustine: Number of Participants With PD or Death as Assessed by Investigator | Trial comparisons |
| Bendamustine Alone vs Obinutuzumab + Bendamustine: Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | Trial comparisons |
| Bendamustine Alone vs Obinutuzumab + Bendamustine: 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.
GET https://conductscience.org/api/trials/v1/NCT01059630
GET https://conductscience.org/api/trials/v1/NCT01059630/registered?page=2