A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01300247
First received: February 14, 2011
Last updated: May 18, 2016
Last verified: March 2016
Results First Received: May 18, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphocytic Leukemia, Chronic
Interventions: Drug: Fludarabine
Drug: Obinutuzumab
Drug: Bendamustine
Drug: Cyclophosphamide

  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
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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 + Fludarabine + Cyclophosphamide Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 milligrams [mg] intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 milligrams per meter square [mg/m^2] IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 nd Cycle 1 Day 2).
Obinutuzumab + Bendamustine Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).

Participant Flow:   Overall Study
    Obinutuzumab + Fludarabine + Cyclophosphamide     Obinutuzumab + Bendamustine  
STARTED     21     20  
COMPLETED     0     0  
NOT COMPLETED     21     20  
Ongoing in Follow-up                 21                 20  



  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.
Safety-Evaluable population included all participants who received any amount of study treatment.

Reporting Groups
  Description
Obinutuzumab + Fludarabine + Cyclophosphamide Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 nd Cycle 1 Day 2).
Obinutuzumab + Bendamustine Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
Total Total of all reporting groups

Baseline Measures
    Obinutuzumab + Fludarabine + Cyclophosphamide     Obinutuzumab + Bendamustine     Total  
Number of Participants  
[units: participants]
  21     20     41  
Age  
[units: years]
Mean (Standard Deviation)
  57.8  (11.1)     62.0  (9.0)     59.8  (10.2)  
Gender  
[units: participants]
     
Female     4     5     9  
Male     17     15     32  



  Outcome Measures
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1.  Primary:   Number of Participants With Human Anti-Human Antibodies (HAHAs)   [ Time Frame: Cycle 1 Day 1 (cycle length = 28 days) up to clinical data cutoff date 24 January 2013 (up to approximately 1.75 years) ]

2.  Secondary:   Area Under the Plasma Concentration-Time Curve (AUC) of Obinutuzumab   [ Time Frame: Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall) ]

3.  Secondary:   Maximum Plasma Concentration (Cmax) of Obinutuzumab   [ Time Frame: Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall) ]

4.  Secondary:   Trough Plasma Concentration (Ctrough) of Obinutuzumab   [ Time Frame: Pre-dose on C1D1, C1D3, 8, 15, C2D1, C4D1, C6D1 ]

5.  Secondary:   Clearance of Obinutuzumab   [ Time Frame: Pre-dose on C1D1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall) ]

6.  Secondary:   Volume of Distribution of Obinutuzumab   [ Time Frame: Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall) ]

7.  Secondary:   Half-Life of Obinutuzumab   [ Time Frame: Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall) ]

8.  Secondary:   Percentage of Participants With Objective Response, Assessed According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines   [ Time Frame: Baseline up to relapse or progression or death from any cause, whichever occurred first up to end of treatment response visit (up to approximately 9 months) ]

9.  Secondary:   Percentage of Participants Who Were Alive and Progression Free   [ Time Frame: Baseline up to relapse or progression or death from any cause, whichever occurred first up to end of treatment response visit (up to 6 months) ]

10.  Secondary:   Percentage of Participants Who Were Alive   [ Time Frame: Baseline up to relapse or progression or death from any cause, whichever occurred first up to end of treatment response visit (up to 6 months) ]

11.  Secondary:   Percentage of Participants Who Had B-Cell Depletion   [ Time Frame: Up to the end of the treatment period, and follow-up at 6 months, 6-12 months and after 12 months up to data cutoff date 24 January 2013 (up to approximately 1.75 years) ]

12.  Secondary:   Percentage of Participants Who Had B-Cell Recovery   [ Time Frame: Follow-up at 6 months, 6-12 months and after 12 months up to data cutoff date 24 January 2013 (up to approximately 1.75 years) ]

13.  Secondary:   Duration of Objective Response, Assessed by the Investigator According to IWCLL Guidelines   [ Time Frame: From first documented objective response up to disease progression or relapse or death, whichever occurred first (up to approximately 3.75 years) ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No


  Serious Adverse Events


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  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
The interim data reported here (up to clinical cutoff date of 24 January 2013) was for participants who had completed treatment response assessment which took place approximately 2 months after the last infusion of study treatment.


  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: Hoffmann-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: NCT01300247     History of Changes
Other Study ID Numbers: GAO4779g
GO01298 ( Other Identifier: Hoffmann-La Roche )
Study First Received: February 14, 2011
Results First Received: May 18, 2016
Last Updated: May 18, 2016
Health Authority: United States: Food and Drug Administration