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A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00848926
First received: February 18, 2009
Last updated: November 6, 2015
Last verified: June 2015
Results First Received: September 15, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Disease, Hodgkin
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
Enrollment period: Feb 2009 - Aug 2009

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 every 3 weeks by intravenous (IV) infusion

Participant Flow for 2 periods

Period 1:   Treatment Period
    Brentuximab Vedotin
STARTED   102 
COMPLETED   18 [1] 
NOT COMPLETED   84 
Progressive disease                45 
Adverse Event                20 
Physician Decision                12 
Withdrawal by Subject                7 
[1] Number who completed 16 cycles of treatment

Period 2:   Follow-up Period
    Brentuximab Vedotin
STARTED   102 [1] 
COMPLETED   90 [2] 
NOT COMPLETED   12 
Lost to Follow-up                7 
Withdrawal by Subject                3 
Not specified                2 
[1] All participants were to be followed after treatment
[2] Completed survival follow-up due to death [57] or study termination by sponsor [33]



  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 every 3 weeks by IV infusion

Baseline Measures
   Brentuximab Vedotin 
Overall Participants Analyzed 
[Units: Participants]
 102 
Age, Customized 
[Units: Years]
Median (Full Range)
 31.0 
 (15 to 77) 
Gender 
[Units: Participants]
 
Female   54 
Male   48 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   7 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   5 
White   89 
More than one race   0 
Unknown or Not Reported   1 
Eastern Cooperative Oncology Group Performance Status [1] 
[Units: Participants]
 
 42 
 60 
2-5   0 
[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
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1.  Primary:   Objective Response Rate by Independent Review Group   [ Time Frame: up to 12 months ]

2.  Secondary:   Complete Remission Rate by Independent Review Group   [ Time Frame: up to 12 months ]

3.  Secondary:   Duration of Objective Response by Kaplan-Meier Analysis   [ Time Frame: up to approximately 4 years ]

4.  Secondary:   Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis   [ Time Frame: up to approximately 4 years ]

5.  Secondary:   Progression-free Survival by Kaplan-Meier Analysis   [ Time Frame: up to approximately 4 years ]

6.  Secondary:   Overall Survival   [ Time Frame: up to approximately 6 years ]

7.  Secondary:   Adverse Events by Severity, Seriousness, and Relationship to Treatment   [ Time Frame: up to 12 months ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Adverse Events by Severity, Seriousness, and Relationship to Treatment
Measure Description Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Time Frame up to 12 months  
Safety Issue Yes  

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 participants who received treatment

Reporting Groups
  Description
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Measured Values
   Brentuximab Vedotin 
Participants Analyzed 
[Units: Participants]
 102 
Adverse Events by Severity, Seriousness, and Relationship to Treatment 
[Units: Participants]
 
Any TEAE   100 
TEAE related to study drug   94 
TEAE with severity grade >/=3   56 
Serious adverse event   25 
Serious adverse event related to study drug   14 
Discontinued treatment due to adverse event   20 

No statistical analysis provided for Adverse Events by Severity, Seriousness, and Relationship to Treatment



8.  Secondary:   Hematology Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]

9.  Secondary:   Chemistry Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]

10.  Secondary:   Area Under the Curve   [ Time Frame: 3 weeks ]

11.  Secondary:   Maximum Serum Concentration   [ Time Frame: 3 weeks ]

12.  Secondary:   Time of Maximum Serum Concentration   [ Time Frame: 3 weeks ]

13.  Other Pre-specified:   B Symptom Resolution   [ Time Frame: up to 12 months ]


  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