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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00848926
First received: February 18, 2009
Last updated: June 30, 2014
Last verified: June 2014
Results First Received: September 15, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   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     28 [2]
NOT COMPLETED     74  
Lost to Follow-up                 2  
Withdrawal by Subject                 1  
Not specified                 2  
Continuing in follow-up                 69  
[1] All participants were to be followed after treatment
[2] Completed survival follow-up due to death



  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  
Number of Participants  
[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]
 
0     42  
1     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
  Show All Outcome Measures

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 23.5 months ]

4.  Secondary:   Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis   [ Time Frame: up to 23.5 months ]

5.  Secondary:   Progression-free Survival by Kaplan-Meier Analysis   [ Time Frame: up to 23.5 months ]

6.  Secondary:   Overall Survival   [ Time Frame: up to 23.5 months ]

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

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
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Time Frame Treatment-emergent adverse events through 30 days after last dose (up to 12 months)
Additional Description No text entered.

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

Serious Adverse Events
    Brentuximab Vedotin  
Total, serious adverse events    
# participants affected / at risk     25/102 (24.51%)  
Blood and lymphatic system disorders    
Thrombocytopenia † 1  
# participants affected / at risk     1/102 (0.98%)  
Gastrointestinal disorders    
Abdominal pain † 1  
# participants affected / at risk     2/102 (1.96%)  
Abdominal pain upper † 1  
# participants affected / at risk     1/102 (0.98%)  
Diarrhoea † 1  
# participants affected / at risk     1/102 (0.98%)  
Gastrointestinal haemorrhage † 1  
# participants affected / at risk     1/102 (0.98%)  
Haematemesis † 1  
# participants affected / at risk     1/102 (0.98%)  
Intestinal perforation † 1  
# participants affected / at risk     1/102 (0.98%)  
Nausea † 1  
# participants affected / at risk     1/102 (0.98%)  
General disorders    
Pyrexia † 1  
# participants affected / at risk     2/102 (1.96%)  
Infections and infestations    
Bronchitis † 1  
# participants affected / at risk     1/102 (0.98%)  
Candidiasis † 1  
# participants affected / at risk     1/102 (0.98%)  
Cellulitis † 1  
# participants affected / at risk     1/102 (0.98%)  
H1N1 influenza † 1  
# participants affected / at risk     1/102 (0.98%)  
Lung infection † 1  
# participants affected / at risk     1/102 (0.98%)  
Pneumocystis jiroveci pneumonia † 1  
# participants affected / at risk     1/102 (0.98%)  
Pneumonia † 1  
# participants affected / at risk     1/102 (0.98%)  
Pyelonephritis † 1  
# participants affected / at risk     2/102 (1.96%)  
Septic shock † 1  
# participants affected / at risk     1/102 (0.98%)  
Soft tissue infection † 1  
# participants affected / at risk     1/102 (0.98%)  
Staphylococcal bacteraemia † 1  
# participants affected / at risk     1/102 (0.98%)  
Urinary tract infection staphylococcal † 1  
# participants affected / at risk     1/102 (0.98%)  
Injury, poisoning and procedural complications    
Wrist fracture † 1  
# participants affected / at risk     1/102 (0.98%)  
Metabolism and nutrition disorders    
Hyperglycaemia † 1  
# participants affected / at risk     1/102 (0.98%)  
Musculoskeletal and connective tissue disorders    
Flank pain † 1  
# participants affected / at risk     1/102 (0.98%)  
Muscular weakness † 1  
# participants affected / at risk     1/102 (0.98%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Diffuse large B-cell lymphoma † 1  
# participants affected / at risk     1/102 (0.98%)  
Hodgkin's disease recurrent † 1  
# participants affected / at risk     1/102 (0.98%)  
Nervous system disorders    
Demyelinating polyneuropathy † 1  
# participants affected / at risk     2/102 (1.96%)  
Diabetic coma † 1  
# participants affected / at risk     1/102 (0.98%)  
Peripheral motor neuropathy † 1  
# participants affected / at risk     1/102 (0.98%)  
Psychiatric disorders    
Mental status changes † 1  
# participants affected / at risk     1/102 (0.98%)  
Respiratory, thoracic and mediastinal disorders    
Haemoptysis † 1  
# participants affected / at risk     1/102 (0.98%)  
Pleural effusion † 1  
# participants affected / at risk     1/102 (0.98%)  
Pneumonitis † 1  
# participants affected / at risk     2/102 (1.96%)  
Pneumothorax † 1  
# participants affected / at risk     2/102 (1.96%)  
Pulmonary embolism † 1  
# participants affected / at risk     2/102 (1.96%)  
Skin and subcutaneous tissue disorders    
Stevens-Johnson syndrome † 1  
# participants affected / at risk     1/102 (0.98%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.0)




  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
Maximum duration of follow-up was 23.5 months; 69 participants remained in survival follow-up at the time of the efficacy analyses.


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