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

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ClinicalTrials.gov Identifier: NCT00866047
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : October 26, 2011
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

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

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

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

1.  Primary:   Objective Response Rate by Independent Review Group   [ Time Frame: up to 12 months ]
  Show Outcome Measure 1

2.  Secondary:   Complete Remission Rate by Independent Review Group   [ Time Frame: up to 12 months ]
  Show Outcome Measure 2

3.  Secondary:   Duration of Objective Response by Kaplan-Meier Analysis   [ Time Frame: up to approximately 3 years ]
  Show Outcome Measure 3

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

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

6.  Secondary:   Overall Survival   [ Time Frame: up to approximately 7 years ]
  Show Outcome Measure 6

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

8.  Secondary:   Hematology Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]
  Show Outcome Measure 8

9.  Secondary:   Chemistry Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]
  Show Outcome Measure 9

10.  Secondary:   Area Under the Curve   [ Time Frame: 3 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Maximum Serum Concentration   [ Time Frame: 3 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Time of Maximum Serum Concentration   [ Time Frame: 3 weeks ]
  Show Outcome Measure 12

13.  Other Pre-specified:   B Symptom Resolution   [ Time Frame: up to 12 months ]
  Show Outcome Measure 13


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information