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Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01874054
First received: June 6, 2013
Last updated: February 21, 2017
Last verified: June 2016
Results First Received: December 22, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Hodgkin Disease
Interventions: Drug: brentuximab vedotin
Drug: bendamustine

  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
June 2013 - July 2016

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 + Bendamustine

Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine

brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion

bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles


Participant Flow for 2 periods

Period 1:   Treatment Period
    Brentuximab Vedotin + Bendamustine
STARTED   55 
COMPLETED   17 
NOT COMPLETED   38 
Progressive Disease                7 
Adverse Event                20 
Physician Decision                3 
Withdrawal by Subject                6 
Non-AE related                2 

Period 2:   Follow-up Period
    Brentuximab Vedotin + Bendamustine
STARTED   51 [1] 
COMPLETED   2 
NOT COMPLETED   49 
Withdrawal by Subject                1 
Continuing in Follow-up                48 
[1] 4 patients withdrew consent and did not enter the follow-up period.



  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.
All subjects who enrolled and received at least 1 dose of brentuximab vedotin.

Reporting Groups
  Description
Brentuximab Vedotin + Bendamustine

Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine

brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion

bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles


Baseline Measures
   Brentuximab Vedotin + Bendamustine 
Overall Participants Analyzed 
[Units: Participants]
 55 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      50  90.9% 
>=65 years      5   9.1% 
Age 
[Units: Years]
Median (Full Range)
 36 
 (19 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      31  56.4% 
Male      24  43.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3   5.5% 
Not Hispanic or Latino      51  92.7% 
Unknown or Not Reported      1   1.8% 
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      6  10.9% 
White      46  83.6% 
More than one race      0   0.0% 
Unknown or Not Reported      3   5.5% 
Region of Enrollment 
[Units: Participants]
 
United States   55 
Eastern Cooperative Group Oncology Performance Status [1] 
[Units: Participants]
Count of Participants
 
    36  65.5% 
    18  32.7% 
    1   1.8% 
[1] 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed <50% of the time; 3= In bed >50% of the time; 4=100% bedridden; 5=Dead


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Remission Rate   [ Time Frame: Up to 16 cycles plus 30 days; approximately 12 months ]

2.  Primary:   Incidence of Adverse Events   [ Time Frame: Up to 16 cycles plus 30 days; approximately 12 months ]

3.  Secondary:   Incidence of Dose-limiting Toxicities   [ Time Frame: Up to 3 weeks; the first cycle of therapy through the first day of Cycle 2. ]

4.  Secondary:   Overall Best Response Rate   [ Time Frame: Every 3 months for up to 3 years ]

5.  Secondary:   Duration of Response   [ Time Frame: Up to 3 years ]

6.  Secondary:   Progression-free Survival   [ Time Frame: Up to 3 years ]


  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
No text entered.


  More Information
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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: Chief Medical Officer
Organization: Seattle Genetics, Inc.
phone: 855-473-2436
e-mail: medinfo@seagen.com



Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01874054     History of Changes
Other Study ID Numbers: SGN35-016
Study First Received: June 6, 2013
Results First Received: December 22, 2016
Last Updated: February 21, 2017