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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
Results First Received: September 15, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Intervention: Drug: brentuximab vedotin

  Participant Flow


  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]
 
 19 
 38 
 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
  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 approximately 3 years ]

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

5.  Secondary:   Progression-free Survival by Kaplan-Meier Analysis   [ Time Frame: up to approximately 3 years ]

6.  Secondary:   Overall Survival   [ Time Frame: up to approximately 7 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


  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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  More Information