Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00622388
First received: February 13, 2008
Last updated: July 3, 2014
Last verified: June 2013
Results First Received: August 4, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma, Large-Cell, Diffuse
Intervention: Drug: Ofatumumab

  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
No text entered.

Reporting Groups
  Description
Ofatumumab Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg

Participant Flow:   Overall Study
    Ofatumumab  
STARTED     81  
COMPLETED     9  
NOT COMPLETED     72  
Disease Progression                 47  
Adverse Event                 6  
Protocol Violation                 3  
Participant Refusal                 1  
Death                 3  
Received Alternate Anticancer Therapy                 8  
Took Prohibited Medication                 2  
Withdrew Consent                 1  
Insurance Expired                 1  



  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.
No text entered.

Reporting Groups
  Description
Ofatumumab Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg

Baseline Measures
    Ofatumumab  
Number of Participants  
[units: participants]
  81  
Age  
[units: Years]
Mean ± Standard Deviation
  64.9  ± 14.51  
Gender  
[units: Participants]
 
Female     36  
Male     45  
Race/Ethnicity, Customized  
[units: participants]
 
Asian     2  
Hispanic or Latino     2  
White     76  
Missing     1  
Number of Participants with the Indicated Prior Therapy [1]
[units: participants]
 
Prior ASCT     25  
Ineligible for ASCT     56  
[1] Study participants had to have either prior autologous stem cell transplant (ASCT) or had to be ineligible for ASCT to be eligible for inclusion.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Objective Response   [ Time Frame: 6-month period from start of treatment (up to Week 24). Participants were followed up for an average of 2.8 months. ]

2.  Primary:   Number of Participants Classified as Responders and Non-responders for Objective Response   [ Time Frame: 6-month period from start of treatment (up to Week 24). Participants were followed up for an average of 2.8 months. ]

3.  Secondary:   Duration of Response   [ Time Frame: From date of randomization of the first participant to when the last participant completed the 6-month follow up visit. Participants were followed up for an average of 2.8 months. ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From date of randomization of the first participant to when the last participant completed the 6-month follow up visit. Participants were followed up for an average of 2.8 months. ]

5.  Secondary:   Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy   [ Time Frame: From date of randomization of the first participant to when the last participant completed the 6-month follow up visit. Participants were followed up for an average of 2.8 months. ]

6.  Secondary:   Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18   [ Time Frame: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24) ]

7.  Secondary:   Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits   [ Time Frame: Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24) ]

8.  Secondary:   Number of Participants Who Experienced at Least One Adverse Event (AE)   [ Time Frame: Participants were followed up for an average of 2.8 months from start of treatment. ]

9.  Secondary:   Percent Change From Screening in Complement (CH50) Levels   [ Time Frame: Screening and post-baseline visits (last visit was to occur 24 months post first dose) ]

10.  Secondary:   AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion   [ Time Frame: Visit 9 (Week 7; up to 11 months after last dose) ]

11.  Secondary:   Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions   [ Time Frame: Visit 2 (Week 0) and Visit 9 (Week 7) ]

12.  Secondary:   Half-life (T1/2) for Ofatumumab at the Eighth Infusion   [ Time Frame: Visit 9 (Week 7; up to 11 months after last dose) ]

13.  Secondary:   Clearance (CL) of Ofatumumab at the Eighth Infusion   [ Time Frame: Visit 9 (Week 7; up to 11 months after last dose) ]

14.  Secondary:   Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion   [ Time Frame: Visit 9 (Week 7; up to 11 months after the last dose) ]

15.  Secondary:   Overall Survival (OS)   [ Time Frame: Participants were followed up for an average of 2.8 months ]
Results not yet posted.   Anticipated Posting Date:   12/2015   Safety Issue:   No


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00622388     History of Changes
Other Study ID Numbers: 111776, GEN415
Study First Received: February 13, 2008
Results First Received: August 4, 2011
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration