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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 ]

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
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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.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Brentuximab Vedotin
Total, other (not including serious) adverse events   
# participants affected / at risk   97/102 (95.10%) 
Blood and lymphatic system disorders   
Anaemia † 1   
# participants affected / at risk   9/102 (8.82%) 
Lymphadenopathy † 1   
# participants affected / at risk   11/102 (10.78%) 
Neutropenia † 1   
# participants affected / at risk   22/102 (21.57%) 
Thrombocytopenia † 1   
# participants affected / at risk   7/102 (6.86%) 
Gastrointestinal disorders   
Abdominal pain † 1   
# participants affected / at risk   15/102 (14.71%) 
Constipation † 1   
# participants affected / at risk   16/102 (15.69%) 
Diarrhoea † 1   
# participants affected / at risk   37/102 (36.27%) 
Nausea † 1   
# participants affected / at risk   43/102 (42.16%) 
Vomiting † 1   
# participants affected / at risk   22/102 (21.57%) 
General disorders   
Chills † 1   
# participants affected / at risk   13/102 (12.75%) 
Fatigue † 1   
# participants affected / at risk   47/102 (46.08%) 
Pain † 1   
# participants affected / at risk   7/102 (6.86%) 
Pyrexia † 1   
# participants affected / at risk   30/102 (29.41%) 
Infections and infestations   
Bronchitis † 1   
# participants affected / at risk   8/102 (7.84%) 
Herpes zoster † 1   
# participants affected / at risk   7/102 (6.86%) 
Sinusitis † 1   
# participants affected / at risk   9/102 (8.82%) 
Upper respiratory tract infection † 1   
# participants affected / at risk   38/102 (37.25%) 
Urinary tract infection † 1   
# participants affected / at risk   6/102 (5.88%) 
Investigations   
Weight decrease † 1   
# participants affected / at risk   6/102 (5.88%) 
Metabolism and nutrition disorders   
Decreased appetite † 1   
# participants affected / at risk   11/102 (10.78%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1   
# participants affected / at risk   19/102 (18.63%) 
Back pain † 1   
# participants affected / at risk   14/102 (13.73%) 
Bone pain † 1   
# participants affected / at risk   8/102 (7.84%) 
Muscle spasms † 1   
# participants affected / at risk   9/102 (8.82%) 
Myalgia † 1   
# participants affected / at risk   17/102 (16.67%) 
Neck pain † 1   
# participants affected / at risk   6/102 (5.88%) 
Pain in extremity † 1   
# participants affected / at risk   10/102 (9.80%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hodgkin's disease recurrent † 1   
# participants affected / at risk   6/102 (5.88%) 
Nervous system disorders   
Dizziness † 1   
# participants affected / at risk   11/102 (10.78%) 
Headache † 1   
# participants affected / at risk   19/102 (18.63%) 
Peripheral motor neuropathy † 1   
# participants affected / at risk   11/102 (10.78%) 
Peripheral sensory neuropathy † 1   
# participants affected / at risk   48/102 (47.06%) 
Psychiatric disorders   
Anxiety † 1   
# participants affected / at risk   11/102 (10.78%) 
Depression † 1   
# participants affected / at risk   8/102 (7.84%) 
Insomnia † 1   
# participants affected / at risk   14/102 (13.73%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1   
# participants affected / at risk   21/102 (20.59%) 
Dyspnoea † 1   
# participants affected / at risk   13/102 (12.75%) 
Nasal congestion † 1   
# participants affected / at risk   6/102 (5.88%) 
Oropharyngeal pain † 1   
# participants affected / at risk   11/102 (10.78%) 
Productive cough † 1   
# participants affected / at risk   6/102 (5.88%) 
Skin and subcutaneous tissue disorders   
Alopecia † 1   
# participants affected / at risk   13/102 (12.75%) 
Hyperhidrosis † 1   
# participants affected / at risk   6/102 (5.88%) 
Night sweats † 1   
# participants affected / at risk   12/102 (11.76%) 
Pruritus † 1   
# participants affected / at risk   16/102 (15.69%) 
Rash † 1   
# participants affected / at risk   14/102 (13.73%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.0)



  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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