A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell 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:
NCT00866047
First received: March 19, 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
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     3 [1]
NOT COMPLETED     55  
Progressive disease                 13  
Adverse Event                 14  
Physician Decision                 14  
Withdrawal by Subject                 5  
Continuing on treatment                 9  
[1] Number who completed 16 cycles of treatment

Period 2:   Follow-up Period
    Brentuximab Vedotin  
STARTED     43 [1]
COMPLETED     12 [2]
NOT COMPLETED     31  
Continuing in follow-up                 31  
[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]
  58  
Age, Customized  
[units: years]
Median ( Full Range )
  52.0  
  ( 14 to 76 )  
Gender  
[units: participants]
 
Female     25  
Male     33  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     7  
White     48  
More than one race     0  
Unknown or Not Reported     2  
Eastern Cooperative Oncology Group Performance Status [1]
[units: participants]
 
0     19  
1     38  
2     1  
3-5     0  
ALK Status [2]
[units: participants]
 
Positive     16  
Negative     42  
[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
[2] 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 ]

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 17.5 months ]

4.  Secondary:   Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis   [ Time Frame: up to 17.5 months ]

5.  Secondary:   Progression-free Survival by Kaplan-Meier Analysis   [ Time Frame: up to 17.5 months ]

6.  Secondary:   Overall Survival   [ Time Frame: up to 17.5 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 ]
  Hide Outcome Measure 9

Measure Type Secondary
Measure Title Chemistry Laboratory Abnormalities >/= Grade 3
Measure Description Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that 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  
Number of Participants Analyzed  
[units: participants]
  58  
Chemistry Laboratory Abnormalities >/= Grade 3  
[units: participants]
 
Any >/= Grade 3 chemistry laboratory abnormality     11  
Aspartate aminotransferase (high)     1  
Calcium (low)     1  
Glucose (high)     4  
Potassium (low)     1  
Sodium (low)     1  
Urate (high)     3  

No statistical analysis provided for Chemistry Laboratory Abnormalities >/= Grade 3



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
Maximum duration of follow-up was 17.5 months; 9 participants were continuing on treatment and 31 participants remained in survival follow-up at the time of the efficacy analyses.


  More Information