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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01059630
First received: January 28, 2010
Last updated: September 27, 2016
Last verified: September 2016
Results First Received: September 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Interventions: Drug: Obinutuzumab
Drug: Bendamustine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 469 participants were screened; out of which 73 participants did not meet the inclusion/exclusion criteria.

Reporting Groups
  Description
Bendamustine Alone Participants received 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.
Obinutuzumab + Bendamustine

Induction phase: Participants received 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 also received 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 disease (SD) then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).


Participant Flow for 2 periods

Period 1:   Induction Period (6 Months)
    Bendamustine Alone   Obinutuzumab + Bendamustine
STARTED   202   194 
Treated   198   194 
COMPLETED   129   156 
NOT COMPLETED   73   38 
Induction ongoing                13                6 
Adverse Event                30                15 
Progressive Disease                14                9 
Withdrawal by Subject                7                2 
Death                2                2 
Physician Decision                2                4 
Unspecified                1                0 
Randomized but not Treated                4                0 

Period 2:   Maintenance Period (up to 2 Years)
    Bendamustine Alone   Obinutuzumab + Bendamustine
STARTED   0 [1]   143 [2] 
COMPLETED   0   35 
NOT COMPLETED   0   108 
Maintenance ongoing                0                46 
Adverse Event                0                8 
Progressive Disease                0                44 
Withdrawal by Subject                0                3 
Death                0                2 
Physician Decision                0                2 
Unspecified                0                3 
[1] Maintenance was not planned for this arm.
[2] Of all participants who completed induction, 13 participants did not start maintenance.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included all participants who were randomized in the study.

Reporting Groups
  Description
Bendamustine Alone Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Obinutuzumab + Bendamustine

Induction phase: Participants received 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 also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.

Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).

Total Total of all reporting groups

Baseline Measures
   Bendamustine Alone   Obinutuzumab + Bendamustine   Total 
Overall Participants Analyzed 
[Units: Participants]
 202   194   396 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.9  (11.4)   61.9  (11.3)   61.9  (11.4) 
Gender 
[Units: Participants]
     
Female   84   84   168 
Male   118   110   228 


  Outcome Measures
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1.  Primary:   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]) ]

2.  Primary:   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]) ]

3.  Secondary:   Number of Participants With PD or Death as Assessed by Investigator   [ 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]) ]

4.  Secondary:   PFS as Assessed by Investigator   [ 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]) ]

5.  Secondary:   Percentage of Participants With Objective Response as Assessed by IRC and Investigator   [ 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 12 months overall) ]

6.  Secondary:   Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC and Investigator   [ 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 12 months overall) ]

7.  Secondary:   Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC and 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) ]

8.  Secondary:   Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC and 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) ]

9.  Secondary:   Duration of Response (DoR) 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]) ]

10.  Secondary:   Disease-Free Survival (DFS) in Participants With CR 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]) ]

11.  Secondary:   Event-free Survival (EFS) 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]) ]

12.  Secondary:   Percentage of Participants Who Died   [ Time Frame: Baseline until death (up to 4.5 years overall) ]

13.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline until death (up to 4.5 years overall) ]

14.  Secondary:   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 1, 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 and 18 ]

15.  Secondary:   CFB in FACT-Lym-Social/Family Well-being Sub-scale Score   [ Time Frame: Baseline, Day 1 of Cycles 1, 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 and 18 ]

16.  Secondary:   CFB in FACT-Lym-Emotional Well-Being Sub-scale Score   [ Time Frame: Baseline, Day 1 of Cycles 1, 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 and 18 ]

17.  Secondary:   CFB in FACT-Lym-Functional Well-Being Sub-scale Score   [ Time Frame: Baseline, Day 1 of Cycles 1, 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 and 18 ]

18.  Secondary:   CFB in FACT-Lym-Lymphoma Sub-scale Score   [ Time Frame: Baseline, Day 1 of Cycles 1, 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 and 18 ]

19.  Secondary:   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 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, and 4 ]

20.  Secondary:   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) ]

21.  Secondary:   CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase   [ Time Frame: Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2 and 4 ]

22.  Secondary:   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) ]

23.  Secondary:   CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score   [ Time Frame: Baseline, Day 1 of Cycles 1, 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 and 18 ]

24.  Secondary:   CFB in FACT-Lym Trial Outcome Index (TOI)   [ Time Frame: Baseline, Day 1 of Cycles 1, 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 and 18 ]

25.  Secondary:   CFB in FACT-Lym Total Score   [ Time Frame: Baseline, Day 1 of Cycles 1, 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 and 18 ]

26.  Secondary:   Time to Deterioration of FACT-Lym TOI   [ Time Frame: Baseline up to approximately 4 years (Baseline, Day 1 of Cycles 1, 3, 4, 5, EOI 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 EOI]; Extension follow-up Months 6 and 18) ]

27.  Secondary:   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), and 12 (FUM12) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01059630     History of Changes
Other Study ID Numbers: GAO4753g
GO01297 ( Other Identifier: Hoffmann-La Roche )
Study First Received: January 28, 2010
Results First Received: September 27, 2016
Last Updated: September 27, 2016
Health Authority: United States: Food and Drug Administration