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Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Celgene Corporation
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01123356
First received: May 4, 2010
Last updated: November 2, 2015
Last verified: July 2012
Results First Received: April 21, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukemia
Interventions: Drug: Ofatumumab
Drug: Lenalidomide

  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
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Reporting Groups
  Description
Oratumumab and Lenalidomide

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles

Participant Flow:   Overall Study
    Oratumumab and Lenalidomide  
STARTED     21  
COMPLETED     14  
NOT COMPLETED     7  
Adverse Event                 2  
Lack of Efficacy                 4  
Withdrawal by Subject                 1  



  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.
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Reporting Groups
  Description
Oratumumab and Lenalidomide

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles

Baseline Measures
    Oratumumab and Lenalidomide  
Number of Participants  
[units: participants]
  21  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     10  
Gender  
[units: participants]
 
Female     4  
Male     17  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     4  
Not Hispanic or Latino     17  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     17  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Overall Response Rate   [ Time Frame: 30 Weeks ]

2.  Secondary:   Frequency of Adverse and Severe Adverse Events   [ Time Frame: 30 weeks ]

3.  Secondary:   Biomarkers Changes During Treatment.   [ Time Frame: 30 Weeks ]

4.  Secondary:   Frequency of Adverse Events   [ Time Frame: 30 weeks ]

5.  Secondary:   Dose Reductions Due to Adverse Events.   [ Time Frame: 30 weeks ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Clinical Trials Network Manager
Organization: Medical University of South Carolina
phone: 843-792-1753
e-mail: adraleta@musc.edu



Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01123356     History of Changes
Other Study ID Numbers: 101376 OFT113297
Study First Received: May 4, 2010
Results First Received: April 21, 2015
Last Updated: November 2, 2015
Health Authority: United States: Food and Drug Administration