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Trial record 1 of 1 for:    gao4915g
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A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414855
First Posted: August 11, 2011
Last Update Posted: December 14, 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.
Information provided by (Responsible Party):
Genentech, Inc.
Results First Submitted: February 5, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma, B-Cell
Interventions: Drug: obinutuzumab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: prednisone
Drug: vincristine

  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
No text entered.

Reporting Groups
  Description
Obinutuzumab + CHOP Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.

Participant Flow:   Overall Study
    Obinutuzumab + CHOP
STARTED   100 
COMPLETED   71 
NOT COMPLETED   29 
Death                17 
Lost to Follow-up                5 
Withdrawal by Subject                7 



  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.
No text entered.

Reporting Groups
  Description
Obinutuzumab + CHOP Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.

Baseline Measures
   Obinutuzumab + CHOP 
Overall Participants Analyzed 
[Units: Participants]
 100 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.9  (14.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      43  43.0% 
Male      57  57.0% 


  Outcome Measures
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1.  Primary:   Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment   [ Time Frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) ]

2.  Primary:   Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment   [ Time Frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) ]

3.  Secondary:   Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment   [ Time Frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) ]

4.  Secondary:   Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment   [ Time Frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) ]

5.  Secondary:   Progression-Free Survival (PFS) as Assessed by the Investigator   [ Time Frame: From the first dose of study treatment to PFS assessment (up to 64 months) ]

6.  Secondary:   Duration of Response (DOR)   [ Time Frame: From the response assessment to relapse, progression, or death (up to 64 months) ]

7.  Secondary:   Percentage of Participants With Adverse Events as a Measure of Safety   [ Time Frame: From the first dose of study treatment to end of study (up to 5 years 4 months) ]

8.  Secondary:   Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)   [ Time Frame: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days) ]

9.  Secondary:   Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab   [ Time Frame: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12 ]

10.  Secondary:   Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab   [ Time Frame: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12 ]

11.  Secondary:   Pharmacokinetics: Clearance (Cl) for Obinutuzumab   [ Time Frame: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12 ]

12.  Secondary:   Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab   [ Time Frame: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12 ]

13.  Secondary:   Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)   [ Time Frame: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12 ]

14.  Secondary:   Pharmacodynamics: Peripheral Blood CD19-positive B-cell Count   [ Time Frame: Up to approximately 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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, Inc.
phone: 800-821-8590
e-mail: genetech@druginfo.com



Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01414855     History of Changes
Other Study ID Numbers: GAO4915g
First Submitted: August 10, 2011
First Posted: August 11, 2011
Results First Submitted: February 5, 2015
Results First Posted: March 19, 2015
Last Update Posted: December 14, 2017