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Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396070
First Posted: July 18, 2011
Last Update Posted: April 5, 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.
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Youn Kim, Stanford University
Results First Submitted: December 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Non-Hodgkin Lymphoma (NHL)
Cutaneous Lymphoma
Cutaneous T-cell Lymphoma (CTCL)
Mycosis Fungoides
Sezary Syndrome
Intervention: Drug: Brentuximab vedotin

  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
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)

Participant Flow:   Overall Study
    Brentuximab Vedotin
STARTED   36 
COMPLETED   17 
NOT COMPLETED   19 
Withdrawal by Subject                2 
Death                2 
Adverse Event                8 
Physician Decision                3 
Lack of Efficacy                4 



  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
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)

Baseline Measures
   Brentuximab Vedotin 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      18  50.0% 
>=65 years      18  50.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  30.6% 
Male      25  69.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   5.6% 
Not Hispanic or Latino      33  91.7% 
Unknown or Not Reported      1   2.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7  19.4% 
White      25  69.4% 
More than one race      0   0.0% 
Unknown or Not Reported      4  11.1% 
CD30 grouping at screening [1] 
[Units: Participants]
 
< 10% CD30 positivity   17 
10% to 50% CD30 positivity   15 
> 50% CD30 positivity   4 
[1] Level of CD30 expression was defined at the % CD30 positivity in the total lymphocytic infiltrate, stratified as 0 to < 10% ; 10% to 50%; or over 50%.
Clinical Stage [1] 
[Units: Participants]
Count of Participants
 
Stage IB   6 
Stage IIB   16 
Stage IV/SS (includes IVA, IVA/SS and III)   14 
[1]

MF/SS staging is based on a tumor-node-metastasis-blood (TNMB) classification system. The most important prognostic factors include overall clinical stage, T-classification, and extracutaneous disease.

Early stage includes MF IA, IB, and IIA. Advanced stage includes MF IIB and higher, including MF/SS IVA.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: 2 years ]

2.  Secondary:   Overall Stable Disease Rate   [ Time Frame: 2 years ]

3.  Secondary:   Overall Partial Response Rate   [ Time Frame: 2 years ]

4.  Secondary:   Overall Non-Evaluable Response   [ Time Frame: 4 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:  
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: Youn H Kim, MD
Organization: Stanford University Medical Center
phone: 650-521-3545
e-mail: younkim@stanford.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Youn Kim, Stanford University
ClinicalTrials.gov Identifier: NCT01396070     History of Changes
Other Study ID Numbers: IRB-21324
LYMNHL0089 ( Other Identifier: OnCore )
SU-06212011-7946 ( Other Identifier: Stanford University )
First Submitted: July 14, 2011
First Posted: July 18, 2011
Results First Submitted: December 28, 2016
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017