Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01396070
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Youn Kim, Stanford University

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
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
Period Title: Overall Study
Started 36
Completed 17
Not Completed 19
Reason Not Completed
Withdrawal by Subject             2
Death             2
Adverse Event             8
Physician Decision             3
Lack of Efficacy             4
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  50.0%
>=65 years
18
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
11
  30.6%
Male
25
  69.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Hispanic or Latino
2
   5.6%
Not Hispanic or Latino
33
  91.7%
Unknown or Not Reported
1
   2.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants
< 10% CD30 positivity 17
10% to 50% CD30 positivity 15
> 50% CD30 positivity 4
[1]
Measure Description: 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Stage IB
6
  16.7%
Stage IIB
16
  44.4%
Stage IV/SS (includes IVA, IVA/SS and III)
14
  38.9%
[1]
Measure Description:

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.

1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description Overall response rate of brentuximab vedotin in this study population.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The percentage was calculated by adding Complete response (CR) + Partial Response (PR) = Overall rate. 3 subjects were not evaluable.
Arm/Group Title Overall Response Rate (%)
Hide Arm/Group Description:
Overall Response Rate of all patients
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: percentage
Everyone evaluable (ORR) Number Analyzed 33 participants
70
Tissue CD30 Expression Group A Number Analyzed 16 participants
56
Tissue CD30 Expression Group B Number Analyzed 14 participants
79
Tissue CD30 Expression Group C Number Analyzed 3 participants
100
Stage IB Number Analyzed 5 participants
83
Stage IIB Number Analyzed 20 participants
94
Stage IV/SS Number Analyzed 8 participants
63
Females Number Analyzed 11 participants
30
Males Number Analyzed 22 participants
69
2.Secondary Outcome
Title Overall Stable Disease Rate
Hide Description

Overall Stable Disease Rate (SD) in this study population.

3 subjects were not evaluable.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
5
  15.2%
3.Secondary Outcome
Title Overall Partial Response Rate
Hide Description

Overall Partial Response Rate (PR) in this study population.

3 subjects were not evaluable.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
21
  63.6%
4.Secondary Outcome
Title Overall Non-Evaluable Response
Hide Description

Overall Non-Evaluable Response of full patient population

3 subjects were not evaluable.

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brentuximab Vedotin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
4
  12.1%
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description All reported AE's on trial
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   23/36 (63.89%)    
Blood and lymphatic system disorders   
Blood disorder * 1  2/36 (5.56%)  5
Febrile Neutropenia * 1  2/36 (5.56%)  2
Hypercalcemia * 1  1/36 (2.78%)  2
Thrombocytopenia * 1  1/36 (2.78%)  4
White blood cell decreased * 1  1/36 (2.78%)  1
Hypomagnesemia * 1  1/36 (2.78%)  1
Gastrointestinal disorders   
Diarrhea * 1  3/36 (8.33%)  3
GVHD * 1  1/36 (2.78%)  1
Acute kidney Injury * 1  1/36 (2.78%)  2
Nausea * 1  1/36 (2.78%)  1
Vomitting * 1  1/36 (2.78%)  1
Infections and infestations   
Sepsis * 1  2/36 (5.56%)  2
Skin Infection * 1  2/36 (5.56%)  2
Musculoskeletal and connective tissue disorders   
Infection and Pain of skin * 1  1/36 (2.78%)  2
Psychiatric disorders   
Confusion * 1  1/36 (2.78%)  1
Reproductive system and breast disorders   
Pneumonia * 1  1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure * 1  1/36 (2.78%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   32/36 (88.89%)    
Blood and lymphatic system disorders   
Aberrant T-cell population (blood) * 1  2/36 (5.56%)  2
Dysphonia * 1  2/36 (5.56%)  2
Hyponatremia * 1  2/36 (5.56%)  2
Gastrointestinal disorders   
Dyspepsia * 1  3/36 (8.33%)  3
General disorders   
Infusion Reaction * 1  2/36 (5.56%)  2
Lower extremity edema * 1  2/36 (5.56%)  2
Pain * 1  2/36 (5.56%)  2
Investigations   
Leukopenia * 1  2/36 (5.56%)  2
LFTs elevated * 1  2/36 (5.56%)  2
Musculoskeletal and connective tissue disorders   
Myalgias * 1  2/36 (5.56%)  2
Nervous system disorders   
Peripheral Neuropathy * 1  2/36 (5.56%)  2
Respiratory, thoracic and mediastinal disorders   
Cough * 1  2/36 (5.56%)  2
Skin and subcutaneous tissue disorders   
Skin eruption * 1  4/36 (11.11%)  4
Social circumstances   
Weight Loss * 1  3/36 (8.33%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
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