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A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)

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ClinicalTrials.gov Identifier: NCT01414205
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : April 24, 2014
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphocytic Leukemia, Chronic
Interventions: Drug: Obinutuzumab
Drug: Corticosteroids

  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
No text entered.

Reporting Groups
  Description
Obinutuzumab 1000 mg Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
Obinutuzumab 2000 mg Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Participant Flow:   Overall Study
    Obinutuzumab 1000 mg   Obinutuzumab 2000 mg
STARTED   41   39 
Received Study Drug   40   38 
COMPLETED   34   32 
NOT COMPLETED   7   7 
Death                5                1 
Lost to Follow-up                1                4 
Physician Decision                0                1 
Randomized but not Treated                1                1 



  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.
No text entered.

Reporting Groups
  Description
Obinutuzumab 1000 mg Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
Obinutuzumab 2000 mg Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
Total Total of all reporting groups

Baseline Measures
   Obinutuzumab 1000 mg   Obinutuzumab 2000 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   39   80 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.0  (10.0)   64.3  (12.4)   65.7  (11.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  39.0%      13  33.3%      29  36.3% 
Male      25  61.0%      26  66.7%      51  63.7% 


  Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: Week 32 ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 4 years, 5 months ]

3.  Secondary:   Number of Participants Surviving at End-of-Study   [ Time Frame: Up to 4 years, 5 months ]

4.  Secondary:   Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to 4 years, 5 months ]

5.  Secondary:   Percentage of Participants With Adverse Events of Interest   [ Time Frame: Up to 4 years, 5 months ]

6.  Secondary:   Percentage of Participants With Adverse Events Leading to Study Discontinuation   [ Time Frame: Up to 4 years, 5 months ]

7.  Secondary:   PK Parameter: Maximum Serum Concentration (Cmax)   [ Time Frame: Day 148 (at end of infusion) ]

8.  Secondary:   PK Parameter: Area Under the Serum Concentration-Time Curve Between Dosing Interval Tau (AUCt )   [ Time Frame: Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion) ]

9.  Secondary:   PK Parameter: Clearance at Steady State (CLss)   [ Time Frame: Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion) ]

10.  Secondary:   PK Parameter: Volume of Distribution at Steady State (Vss)   [ Time Frame: Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion) ]

11.  Secondary:   PK Parameter: Terminal Half-Life (t1/2)   [ Time Frame: Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion) ]

12.  Secondary:   PK: Serum Concentrations of Obinutuzumab (Follow-Up Visits)   [ Time Frame: Months 3, 6, 9, and 12 ]

13.  Secondary:   Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Depletion   [ Time Frame: Up to 4 years, 5 months ]

14.  Secondary:   Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Recovery   [ Time Frame: Up to 4 years, 5 months ]

15.  Secondary:   Duration of Response   [ Time Frame: Up to 4 years, 5 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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

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: Hoffman-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01414205     History of Changes
Other Study ID Numbers: GAO4768g
GO25677 ( Other Identifier: Hoffmann-La Roche )
First Submitted: August 10, 2011
First Posted: August 11, 2011
Results First Submitted: March 21, 2014
Results First Posted: April 24, 2014
Last Update Posted: April 17, 2017