We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332968
First Posted: April 11, 2011
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
German Low Grade Lymphoma Study Group
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: February 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Interventions: Drug: Obinutuzumab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Bendamustine
Drug: Rituximab

  Participant Flow
  Hide Participant Flow

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
Eleven patients withdrew from the study after randomization but prior to receiving study treatment.

Reporting Groups
  Description
Rituximab+Chemotherapy - Induction Period Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
Obinutuzumab+Chemotherapy - Induction Period Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
Rituximab+Chemotherapy - Maintenance Period The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period.
Obinutuzumab+Chemotherapy - Maintenance Period The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period.
Rituximab+Chemotherapy - Observation Period Rituximab+Chemotherapy – Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
Obinutuzumab+Chemotherapy - Observation Period Obinutuzumab+Chemotherapy – Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
Rituximab+Chemotherapy - Follow-Up Period Finally, participants were followed during a 5-year follow-up period.
Obinutuzumab+Chemotherapy - Follow-Up Period Finally, participants were followed during a 5-year follow-up period.

Participant Flow for 3 periods

Period 1:   Induction Period
    Rituximab+Chemotherapy - Induction Period   Obinutuzumab+Chemotherapy - Induction Period   Rituximab+Chemotherapy - Maintenance Period   Obinutuzumab+Chemotherapy - Maintenance Period   Rituximab+Chemotherapy - Observation Period   Obinutuzumab+Chemotherapy - Observation Period   Rituximab+Chemotherapy - Follow-Up Period   Obinutuzumab+Chemotherapy - Follow-Up Period
STARTED   699   702   0   0   0   0   0   0 
COMPLETED   641   646   0   0   0   0   0   0 
NOT COMPLETED   58   56   0   0   0   0   0   0 
Withdrawal by Subject                3                5                0                0                0                0                0                0 
Protocol Violation                3                4                0                0                0                0                0                0 
Progressive disease                15                7                0                0                0                0                0                0 
Physician Decision                6                1                0                0                0                0                0                0 
Other                2                2                0                0                0                0                0                0 
Non-compliance                1                0                0                0                0                0                0                0 
Death                1                4                0                0                0                0                0                0 
Adverse Event                23                26                0                0                0                0                0                0 
Randomized, but not treated                4                7                0                0                0                0                0                0 

Period 2:   Maintenance/Observation Period
    Rituximab+Chemotherapy - Induction Period   Obinutuzumab+Chemotherapy - Induction Period   Rituximab+Chemotherapy - Maintenance Period   Obinutuzumab+Chemotherapy - Maintenance Period   Rituximab+Chemotherapy - Observation Period   Obinutuzumab+Chemotherapy - Observation Period   Rituximab+Chemotherapy - Follow-Up Period   Obinutuzumab+Chemotherapy - Follow-Up Period
STARTED   0   0   612   624   12   11   0   0 
COMPLETED   0   0   399   417   2   2   0   0 
NOT COMPLETED   0   0   213   207   10   9   0   0 
Withdrawal by Subject                0                0                10                5                0                0                0                0 
Protocol Violation                0                0                1                1                0                0                0                0 
Progressive disease                0                0                72                39                0                0                0                0 
Physician Decision                0                0                14                19                0                0                0                0 
Other                0                0                4                5                0                0                0                0 
Non-compliance                0                0                2                3                0                1                0                0 
Lost to Follow-up                0                0                1                2                0                0                0                0 
Death                0                0                5                6                0                0                0                0 
Adverse Event                0                0                50                65                0                0                0                0 
Treatment ongoing                0                0                54                62                10                8                0                0 

Period 3:   Follow-Up Period
    Rituximab+Chemotherapy - Induction Period   Obinutuzumab+Chemotherapy - Induction Period   Rituximab+Chemotherapy - Maintenance Period   Obinutuzumab+Chemotherapy - Maintenance Period   Rituximab+Chemotherapy - Observation Period   Obinutuzumab+Chemotherapy - Observation Period   Rituximab+Chemotherapy - Follow-Up Period   Obinutuzumab+Chemotherapy - Follow-Up Period
STARTED   0   0   0   0   0   0   542   531 
COMPLETED   0   0   0   0   0   0   0   0 
NOT COMPLETED   0   0   0   0   0   0   542   531 
Death                0                0                0                0                0                0                38                22 
Follow-up ongoing                0                0                0                0                0                0                502                505 
Withdrawal by Subject                0                0                0                0                0                0                1                2 
Lost to Follow-up                0                0                0                0                0                0                1                2 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
The intent-to treat (ITT) population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.

Reporting Groups
  Description
Rituximab+Chemotherapy - Induction Period Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
Obinutuzumab+Chemotherapy - Induction Period Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
Total Total of all reporting groups

Baseline Measures
   Rituximab+Chemotherapy - Induction Period   Obinutuzumab+Chemotherapy - Induction Period   Total 
Overall Participants Analyzed 
[Units: Participants]
 699   702   1401 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.1  (12.3)   58.9  (11.6)   58.5  (11.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      374  53.5%      365  52.0%      739  52.7% 
Male      325  46.5%      337  48.0%      662  47.3% 
Age Continuous in Follicular Lymphoma Sub-Population [1] 
[Units: Years]
Mean (Standard Deviation)
 57.7  (12.2)   58.2  (11.5)   57.9  (11.9) 
[1] Age continuous for participants with follicular lymphoma (FL) in each arm, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 in each arm).
Gender in Follicular Lymphoma Sub-Population [1] 
[Units: Participants]
     
Female   321   318   639 
Male   280   283   563 
[1] Gender of participants with follicular lymphoma, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 for each arm).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months) ]

2.  Secondary:   Progression-Free Survival in the Overall Study Population, Investigator-Assessed   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months) ]

3.  Secondary:   Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months) ]

4.  Secondary:   Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months) ]

5.  Secondary:   Overall Response (Follicular Lymphoma Population), Investigator-Assessed   [ Time Frame: Baseline up to end of induction period (up to approximately 7 months) ]

6.  Secondary:   Overall Response (Overall Study Population), Investigator-Assessed   [ Time Frame: Baseline up to end of induction period (up to approximately 7 months) ]

7.  Secondary:   Complete Response (Follicular Lymphoma Population), Investigator-Assessed   [ Time Frame: Baseline up to end of induction period (up to approximately 7 months) ]

8.  Secondary:   Complete Response (Overall Study Population), Investigator-Assessed   [ Time Frame: Baseline up to end of induction period (up to approximately 7 months) ]

9.  Secondary:   Overall Response (Follicular Lymphoma Population), IRC-Assessed   [ Time Frame: Baseline up to end of induction period (up to approximately 7 months) ]

10.  Secondary:   Overall Response (Overall Study Population), IRC-Assessed   [ Time Frame: Baseline up to end of induction period (up to approximately 7 months) ]

11.  Secondary:   Complete Response (Follicular Lymphoma Population), IRC-Assessed   [ Time Frame: Baseline up to end of induction period (up to approximately 7 months) ]

12.  Secondary:   Complete Response (Overall Study Population), IRC-Assessed   [ Time Frame: Baseline up to end of induction period (up to approximately 7 months)] ]

13.  Secondary:   Overall Survival (Follicular Lymphoma Population)   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months ]

14.  Secondary:   Overall Survival (Overall Study Population)   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months ]

15.  Secondary:   Event-Free Survival (Follicular Lymphoma Population)   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months) ]

16.  Secondary:   Event-Free Survival (Overall Study Population)   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months ]

17.  Secondary:   Disease-Free Survival (Follicular Lymphoma Population)   [ Time Frame: From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months) ]

18.  Secondary:   Disease-Free Survival (Overall Study Population)   [ Time Frame: From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months ]

19.  Secondary:   Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed   [ Time Frame: From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months ]

20.  Secondary:   Duration of Response (DOR) (Overall Study Population), Investigator-Assessed   [ Time Frame: From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months) ]

21.  Secondary:   Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months ]

22.  Secondary:   Time to Next Anti-Lymphoma Treatment (Overall Study Population)   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months) ]

23.  Secondary:   Percentage of Participants With Adverse Events   [ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months) ]

24.  Secondary:   Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)   [ Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months) ]

25.  Secondary:   Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)   [ Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months) ]

26.  Secondary:   Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)   [ Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months) ]

27.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)   [ Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months) ]

28.  Secondary:   Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase   [ Time Frame: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 4 years and 7 months) ]

29.  Secondary:   Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase   [ Time Frame: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 4 years and 7 months) ]

30.  Secondary:   Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase   [ Time Frame: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 4 years and 7 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01332968     History of Changes
Other Study ID Numbers: BO21223
2010-024132-41 ( EudraCT Number )
First Submitted: April 8, 2011
First Posted: April 11, 2011
Results First Submitted: February 3, 2017
Results First Posted: June 7, 2017
Last Update Posted: September 12, 2017