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A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00866047
First received: March 19, 2009
Last updated: February 2, 2017
Last verified: December 2016
History of Changes
Results First Received: September 15, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-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: Jun 2009 - May 2010

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   58 
COMPLETED   10 [1] 
NOT COMPLETED   48 
Progressive disease                13 
Adverse Event                16 
Physician Decision                14 
Withdrawal by Subject                5 
[1] Number who completed 16 cycles of treatment

Period 2:   Follow-up Period
    Brentuximab Vedotin
STARTED   58 [1] 
COMPLETED   53 [2] 
NOT COMPLETED   5 
Lost to Follow-up                5 
[1] All participants were to be followed after treatment
[2] Completed survival follow-up due to death [25] or study completion [28]



  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]
 		 58 
Age, Customized 
[Units: Years]
Median (Full Range) 		 52.0 
 (14 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      25  43.1% 
Male      33  56.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		 
American Indian or Alaska Native      0   0.0% 
Asian      1   1.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7  12.1% 
White      48  82.8% 
More than one race      0   0.0% 
Unknown or Not Reported      2   3.4% 
Eastern Cooperative Oncology Group Performance Status [1] 
[Units: Participants]
 		 
0   19 
1   38 
2   1 
3-5   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
ALK Status [1] 
[Units: Participants]
 		 
Positive   16 
Negative   42 
[1] Immunophenotype status with respect to anaplastic lymphoma kinase (ALK) protein


  Outcome Measures
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1.  Primary:   Objective Response Rate by Independent Review Group   [ Time Frame: up to 12 months ]
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2.  Secondary:   Complete Remission Rate by Independent Review Group   [ Time Frame: up to 12 months ]
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3.  Secondary:   Duration of Objective Response by Kaplan-Meier Analysis   [ Time Frame: up to approximately 3 years ]
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4.  Secondary:   Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis   [ Time Frame: up to approximately 3 years ]
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5.  Secondary:   Progression-free Survival by Kaplan-Meier Analysis   [ Time Frame: up to approximately 3 years ]
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6.  Secondary:   Overall Survival   [ Time Frame: up to approximately 7 years ]
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7.  Secondary:   Adverse Events by Severity, Seriousness, and Relationship to Treatment   [ Time Frame: up to 12 months ]
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8.  Secondary:   Hematology Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]
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9.  Secondary:   Chemistry Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]
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10.  Secondary:   Area Under the Curve   [ Time Frame: 3 weeks ]
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11.  Secondary:   Maximum Serum Concentration   [ Time Frame: 3 weeks ]
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12.  Secondary:   Time of Maximum Serum Concentration   [ Time Frame: 3 weeks ]
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13.  Other Pre-specified:   B Symptom Resolution   [ Time Frame: up to 12 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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  More Information
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