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)

• ClinicalTrials.gov Identifier: NCT01059630
• Recruitment Status: Completed
• First Posted: February 1, 2010
• Results First Posted: November 17, 2016
• Last Update Posted: January 13, 2020
• Sponsor: Genentech, Inc.
• Collaborator: Roche Pharma AG
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

Brief Summary:

This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).

Condition or disease	Intervention/treatment	Phase
Non-Hodgkin's Lymphoma	Drug: Obinutuzumab; Drug: Bendamustine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 413 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma
• Actual Study Start Date: April 30, 2010
• Actual Primary Completion Date: September 30, 2014
• Actual Study Completion Date: November 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Bendamustine Alone; Participants will receive bendamustine 120 milligrams per meter square (mg/m^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Drug: Bendamustine; IV infusion.
Experimental: Obinutuzumab + Bendamustine; Induction phase: Participants will receive bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants will also receive obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with complete response (CR), partial response (PR) or stable response (SD) then will receive obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurs first).	Drug: Obinutuzumab; IV infusion.; Other Name: RO5072759; GA101; Drug: Bendamustine; IV infusion.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death [ Time Frame: 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.
2. Progression-Free Survival (PFS) as Assessed by IRC [ Time Frame: 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 Outcome Measures :

1. Number of Participants With PD or Death as Assessed by Investigator [ Time Frame: 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.
2. PFS as Assessed by Investigator [ Time Frame: 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.
3. Percentage of Participants With Objective Response as Assessed by IRC [ Time Frame: 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.
4. Percentage of Participants With Objective Response as Assessed by Investigator [ Time Frame: 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.
5. Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC [ Time Frame: 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.
6. Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator [ Time Frame: 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).
7. Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC [ Time Frame: 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.
8. Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator [ Time Frame: 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).
9. Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC [ Time Frame: 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) ]
   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.
10. Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator [ Time Frame: 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) ]
    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.
11. Duration of Response (DoR) as Assessed by IRC [ Time Frame: Baseline until PD or death, whichever occurred first (up to approximately 5 years) ]
    DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease & disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion >1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015.
12. Duration of Response (DoR) as Assessed by Investigator [ Time Frame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) ]
    DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and 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 presence of measurable disease. 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 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method.
13. Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC [ Time Frame: Baseline until PD or death, whichever occurred first (up to approximately 5 years) ]
    DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. 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. 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 a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.
14. Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator [ Time Frame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) ]
    DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. 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. 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 a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.
15. Event-free Survival (EFS) as Assessed by IRC [ Time Frame: Baseline until PD or death, whichever occurred first (up to approximately 5 years) ]
    EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. 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 a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.
16. Percentage of Participants Who Died [ Time Frame: Baseline until death (up to 8.5 years overall) ]
17. Overall Survival (OS) [ Time Frame: Baseline until death (up to 8.5 years overall) ]
    OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.
18. Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 ]
    The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
19. CFB in FACT-Lym-Social/Family Well-being Sub-scale Score [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 ]
    The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
20. CFB in FACT-Lym-Emotional Well-Being Sub-scale Score [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 ]
    The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
21. CFB in FACT-Lym-Functional Well-Being Sub-scale Score [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 ]
    The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
22. CFB in FACT-Lym-Lymphoma Sub-scale Score [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 ]
    The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
23. CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14 ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.
24. CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase [ Time Frame: Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6) ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.
25. CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14 ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.
26. CFB in EQ-5D VAS Score During Maintenance Phase [ Time Frame: Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6) ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.
27. CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 ]
    The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
28. CFB in FACT-Lym Trial Outcome Index (TOI) [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 ]
    TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
29. CFB in FACT-Lym Total Score [ Time Frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 ]
    FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
30. Time to Deterioration of FACT-Lym TOI [ Time Frame: Baseline up to approximately 8.5 years ]
    The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
31. Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores [ Time Frame: Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6) ]
    FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0-116). FACT-Lym total score is sum of 42 items (total score ranges from 0-168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• History of histologically documented, B-lymphocyte antigen cluster of differentiation 20 plus (CD20+), iNHL
• Refractory to any previous regimen containing rituximab (defined by participants who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen)
• Previously treated with a maximum of four unique chemotherapy containing treatment regimens
• All participants must have at least one bi-dimensionally measurable lesion (greater than [>]1.5 centimeters (cm) in its largest dimension by computed tomography [CT] scan)

Exclusion Criteria:

• Prior use of any monoclonal antibody (other than anti-CD20) within 3 months prior to the start of Cycle 1, prior treatment with obinutuzumab was not allowed
• Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
• Prior treatment with bendamustine (within 2 years of the start of Cycle 1)
• Prior allogeneic stem cell transplant
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
• History of sensitivity to mannitol
• Central nervous system lymphoma or prior diffuse large B-cell lymphoma (DLBCL), histological evidence of transformation to high grade or diffuse large B-cell lymphoma
• History of other malignancy that could affect compliance with the protocol or interpretation of results
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks
• Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
• Vaccination with a live vaccine a minimum of 28 days prior to randomization
• Recent major surgery (within 4 weeks), other than for diagnosis
• Presence of positive test results for Hepatitis B surface antigen (HBsAg); antibody to hepatitis B core antigen [anti-HBc]) with detectable viral load (positive hepatitis B virus [HBV] deoxyribo-nucleic acid [DNA]) or Hepatitis C
• Participants with chronic hepatitis B or seropositive occult (HBV) infection
• Participants with seronegative occult HBV infection or past HBV infection (defined as anti-HBc positive and HBV DNA negative) could be eligible if they were willing to be followed according to the protocol for HBV DNA testing
• Participants positive for Hepatitis C virus (HCV) antibody were eligible only if polymerase chain reaction(PCR) was negative for HCV Ribonucleic acid (RNA)
• Known history of human immunodeficiency virus (HIV) seropositive status
• Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries
• Women who are pregnant or lactating
• Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
• Ongoing corticosteroid use >30 milligrams per day (mg/day) prednisone or equivalent

Contacts and Locations

Locations

United States, Alabama

Southern Cancer Center, PC

Mobile, Alabama, United States, 36608

United States, Arizona

Dr. Donald W. Hill, MD, FACP

Casa Grande, Arizona, United States, 85122

United States, Arkansas

Highlands Oncology Group

Rogers, Arkansas, United States, 72758

United States, California

Kaiser Permanente - Bellflower

Bellflower, California, United States, 90706

Bay Area Cancer Research Group, LLC

Pleasant Hill, California, United States, 94523

Sharp Memorial Hospital

San Diego, California, United States, 92123

United States, District of Columbia

Georgetown University Medical Center Lombardi Cancer Center

Washington, District of Columbia, United States, 20007

Washington DC VA Med Center; Hematology

Washington, District of Columbia, United States, 20422

United States, Florida

University of Florida

Gainesville, Florida, United States, 32607

University of Florida; Division of Hematology/Oncology

Gainesville, Florida, United States, 33610-0277

Md Anderson Cancer Center Orlando

Orlando, Florida, United States, 32806

United States, Illinois

Rush Cancer Institute

Chicago, Illinois, United States, 60612

Quincy Medical Group

Quincy, Illinois, United States, 62301

Simmons Cancer Institute

Springfield, Illinois, United States, 62794-9677

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Kentucky

Univ Louisville School of Med

Louisville, Kentucky, United States, 40202

United States, Maine

New England Cancer Specialists

Scarborough, Maine, United States, 04074

United States, Maryland

Meritus Center for Clinical Research

Hagerstown, Maryland, United States, 21740

United States, Missouri

Capitol Comprehensive CA Care

Jefferson City, Missouri, United States, 65101

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Hematology Oncology Assoc SJ

Mount Holly, New Jersey, United States, 08060

United States, New Mexico

San Juan Oncology

Farmington, New Mexico, United States, 87401

United States, Ohio

The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

Columbus, Ohio, United States, 43219

United States, Oregon

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97210

Pacific Oncology, PC

Portland, Oregon, United States, 97210

OHSU Ctr for Health & Healing

Portland, Oregon, United States, 97239

United States, Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States, 15224

United States, South Dakota

Sanford Health System

Sioux Falls, South Dakota, United States, 57105

United States, Texas

South Texas Inst of Cancer

Corpus Christi, Texas, United States, 78405

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

United States, Washington

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

United States, Wisconsin

Univ of Wisconsin Hosp & Clin

Madison, Wisconsin, United States, 53792

Austria

Lkh-Univ. Klinikum Graz

Graz, Austria, 8036

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

Salzburg, Austria, 5020

Medizinische Universität Wien

Wien, Austria, 1090

Belgium

ZNA Stuivenberg

Antwerpen, Belgium, 2060

AZ Groeninge

Kortrijk, Belgium, 8500

CHU Ambroise Paré

Mons, Belgium, 7000

Canada, Alberta

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, British Columbia

British Columbia Cancer Agency

Kelowna, British Columbia, Canada, V1Y 5L3

British Columbia Cancer Agency

Vancouver, British Columbia, Canada, V5Z 1H6

Canada, Manitoba

Manitoba Cancer Care

Winnipeg, Manitoba, Canada, R3E 0V9

Canada, New Brunswick

Moncton Hospital

Moncton, New Brunswick, Canada, E1C 6Z8

Canada, Ontario

Toronto East General Hospital; Main Pharmacy G Wing Basement

East York, Ontario, Canada, M4C 3E7

Princess Margaret Hospital

Toronto, Ontario, Canada, M4X 1K9

Canada, Quebec

CHUM-Hosp Notre Dame

Montreal, Quebec, Canada, H2X 3E4

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal, Quebec, Canada, H3T 1E2

CHA Hopital de I enfant-Jesus

Quebec City, Quebec, Canada, G1J 1Z4

Canada, Saskatchewan

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada, S4T 7T1

Czechia

Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

Brno, Czechia, 625 00

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Czechia, 500 05

I Interni klinika; Vseobecna fakultni nemocnice

Prague 2, Czechia, 128 08

France

Institut Bergonie; Hematologie Oncologie

Bordeaux, France, 33076

Polyclinique Bordeaux Nord

Bordeaux, France, 33300

Hopital Henri Mondor

Creteil, France, 94010

CH Dijon

Dijon, France, 21079

Centre d'oncologie-radiotherap

LeMans, France, 72015

Hopital Claude Huriez

Lille, France, 59037

Centre Leon Berard

Lyon, France, 69008

Hopital Bon Secour

Metz, France, 57038

CHU Hopital Saint Eloi

Montpellier, France, 34295

Hopital Hotel Dieu Et Hme; Clinique Dermatologique

Nantes, France, 44093

Hopital Necker

Paris, France, 75015

Hopital Saint Louis; Dermatologie 1

Paris, France, 75475

CHU Bordeaux

Pessac, France, 33604

Centre Hospitalier Lyon Sud; Hematolgie

Pierre Benite, France, 69495

Chu De Poitiers; Chu La Miletrie

Poitiers, France, 86021

CHU de Reims

Reims, France, 51100

Hopital Pontchaillou

Rennes, France, 35033

Centre Henri Becquerel

Rouen, France, 76038

Clinique Ste Anne

Strasbourg, France, 67000

CHRU de; Maladies, Vasculaires

Vandoeuvre, France, 54511

Germany

St. Johannes Hospital Duisburg

Duisburg, Germany, 47166

Klinikum Frankfurt Höchst

Frankfurt am Main, Germany, 65929

Asklepios Klinik St. Georg

Hamburg, Germany, 20099

Universitaetsklinikum Leipzig

Leipzig, Germany, 04103

Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III

München, Germany, 81377

Schwarzwald-Baar Klinikum GmbH

Villingen-Schwenningen, Germany, 78052

Italy

Azienda Ospedaliera Universitaria di Modena

Modena, Emilia-Romagna, Italy, 41100

Azienda Ospedaliera Univ, Ematologica

Udine, Friuli-Venezia Giulia, Italy, 33100

Azienda Ospedaliera Univ

Roma, Lazio, Italy, 00133

Universita La Sapienza

Roma, Lazio, Italy, 00161

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

Milano, Lombardia, Italy, 20133

Irccs Policlinico San Matteo; Divisione Di Ematologia

Pavia, Lombardia, Italy, 27100

Azienda Ospedale San Giovanni

Torino, Piemonte, Italy, 10126

Ospedale Mauriziano Umberto I

Torino, Piemonte, Italy, 10128

Ospedale Vito Fazzi

Lecce, Puglia, Italy, 73100

Azienda Ospedaliero Univ

Catania, Sicilia, Italy, 95124

Azienda Ospedaliera Univ

Firenze, Toscana, Italy, 50141

Netherlands

VU MEDISCH CENTRUM; Dept. of Medical Oncology

Amsterdam, Netherlands, 1081 HV

Haga Ziekenhuis

Den Haag, Netherlands, 2504 LN

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands, 3371 NM

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

Rotterdam, Netherlands, 3015 CE

Erasmus MC

Rotterdam, Netherlands, 3015 GD

Russian Federation

Regional Oncology Hospital

Irkutsk, Russian Federation, 664035

Blokhin Cancer Research Center; Combined Treatment

Moscow, Russian Federation, 115478

City Clin Hosp n.a. S.P.Botkin

Moscow, Russian Federation, 125101

Russian Hema Res Ctr of RAMS

Moscow, Russian Federation, 125167

Republican Clinical Hospital n.a. Baranov; Haematology

Petrozavodsk, Russian Federation, 185019

Ryazan Regional Clinical Hosp

Ryazan, Russian Federation, 390039

St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

Saint-Petersburg, Russian Federation, 197022

SRI of Hematology and Transfusiology

St. Petersburg, Russian Federation, 191024

Spain

Clinica Universitaria de Navarra

Pamplona, Navarra, Spain, 31008

Hospital Univ. Nuestra Señora de Valme

Sevillac, Sevilla, Spain, 41014

Hospital Universitario Basurto

Bilbao, Vizcaya, Spain, 48013

Hospital Universitario de la Princesa; Servicio de Hematologia

Madrid, Spain, 28006

Hospital Universitario La Paz

Madrid, Spain, 28034

Sweden

Skånes University Hospital, Skånes Department of Onclology

Lund, Sweden, 22185

Hematology Center; Karolinska Univ Hosp

Stockholm, Sweden, 14186

Norrlands Uni Hospital; Onkologi Avd.

Umeå, Sweden, 901 85

Onc Clin, Akademiska Sjukhuset

Uppsala, Sweden, 751 85

Switzerland

Universitaetsspital Basel; Onkologie

Basel, Switzerland, 4031

Inselspital Bern; Universitätsklinik für medizinische Onkologie

Bern, Switzerland, 3010

Kantonsspital Graubünden;Onkologie und Hämatologie

Chur, Switzerland, 7000

United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom, G12 0YN

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Barts & London School of Med; Medical Oncology

London, United Kingdom, EC1A 7BE

Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE7 7DN

Singleton Hospital; Pharmacy Department

Swansea, United Kingdom, SA2 8QA

Sponsors and Collaborators

Genentech, Inc.

Roche Pharma AG

Investigators

• Study Director: Clinical Trials; Genentech, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pott C, Sehn LH, Belada D, Gribben J, Hoster E, Kahl B, Kehden B, Nicolas-Virelizier E, Spielewoy N, Fingerle-Rowson G, Harbron C, Mundt K, Wassner-Fritsch E, Cheson BD. MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial. Leukemia. 2020 Feb;34(2):522-532. doi: 10.1038/s41375-019-0559-9. Epub 2019 Aug 28.

Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

Cheson BD, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben JG, Lennard A, Lugtenburg PJ, Fingerle-Rowson G, Mattiello F, Knapp A, Sehn LH. Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol. 2018 Aug 1;36(22):2259-2266. doi: 10.1200/JCO.2017.76.3656. Epub 2018 Mar 27.

Sehn LH, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben J, Lennard A, Lugtenburg PJ, Dimier N, Wassner-Fritsch E, Fingerle-Rowson G, Cheson BD. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1081-1093. doi: 10.1016/S1470-2045(16)30097-3. Epub 2016 Jun 23.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01059630
• Other Study ID Numbers: GAO4753g; GO01297 ( Other Identifier: Hoffmann-La Roche ); 2009-015504-25 ( EudraCT Number )
• First Posted: February 1, 2010
• Results First Posted: November 17, 2016
• Last Update Posted: January 13, 2020
• Last Verified: December 2019

Keywords provided by Genentech, Inc.:

follicular; follicular lymphoma

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bendamustine Hydrochloride; Obinutuzumab; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological