Ofatumumab and Bortezomib in Subjects With Relapsed CD20+Diffuse Large B Cell, Follicular, or Mantle Cell Lymphoma

This study has been terminated.
(Study closed by PI due to lower than expected accrual.)
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
GlaxoSmithKline
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01397591
First received: July 13, 2011
Last updated: July 28, 2014
Last verified: July 2014
Results First Received: June 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Interventions: Biological: Ofatumumab
Drug: Bortezomib

  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
3 subjects enrolled on study but 1 of the 3 was a screen failure so only 2 subjects were assigned to study treatment.

Reporting Groups
  Description
Ofatumumab in Combination With Bortezomib All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.

Participant Flow:   Overall Study
    Ofatumumab in Combination With Bortezomib  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  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
Ofatumumab in Combination With Bortezomib All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.

Baseline Measures
    Ofatumumab in Combination With Bortezomib  
Number of Participants  
[units: participants]
  2  
Age  
[units: years]
Mean ± Standard Deviation
  63.5  ± 10.6  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     1  
Gender  
[units: participants]
 
Female     1  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate of Ofatumumab in Combination With Bortezomib in Patients With Relapsed CD20+ (Cluster of DIfferentiation Antigen 20) Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma   [ Time Frame: Every 2 cycles during treatment and then every 3 months for 2 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to every 3 months for 2 years ]

3.  Secondary:   Progression Free Survival   [ Time Frame: Up to every 3 months for 2 years ]

4.  Secondary:   Disease Free Survival   [ Time Frame: Up to every 3 months for 2 years ]

5.  Secondary:   Number of Participants With Adverse Events (Toxicity)   [ Time Frame: Days 1, 8, and 15 of each course and 4-6 weeks after final treatment ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Jeff Donovan
Organization: OHSU Knight Investigational Cancer Services
phone: 503-494-7702
e-mail: mastersj@ohsu.edu


No publications provided


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01397591     History of Changes
Other Study ID Numbers: IRB00007042, NCI-2011-01032, OFT113735
Study First Received: July 13, 2011
Results First Received: June 18, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration