A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
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ClinicalTrials.gov Identifier: NCT00947856 |
Recruitment Status :
Completed
First Posted : July 28, 2009
Results First Posted : May 26, 2014
Last Update Posted : February 2, 2017
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Sponsor:
Seagen Inc.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin |
Intervention |
Drug: brentuximab vedotin |
Enrollment | 110 |
Participant Flow
Recruitment Details | Jul 2009 - Mar 2013 |
Pre-assignment Details |
Arm/Group Title | BV Extension | BV Retreatment |
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Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment) | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse) |
Period Title: Treatment Period | ||
Started | 78 | 32 [1] |
Completed | 0 | 0 [2] |
Not Completed | 78 | 32 |
Reason Not Completed | ||
Progressive Disease | 33 | 12 |
Adverse Event | 15 | 9 |
Physician Decision | 14 | 6 |
Study Stopped by Sponsor | 4 | 4 |
Withdrawal by Subject | 12 | 1 |
[1]
Two patients in extension arm re-enrolled in retreatment arm and are represented in both arms
[2]
Patients treated until disease progression, unacceptable toxicity or study closure
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Period Title: Follow-up Period | ||
Started | 78 | 32 [1] |
Completed | 27 | 9 [2] |
Not Completed | 51 | 23 |
Reason Not Completed | ||
Study Stopped by Sponsor | 40 | 20 |
Re-enrolled for Retreatment | 2 | 3 |
Lost to Follow-up | 7 | 0 |
Patient unavailable for site visits | 1 | 0 |
Withdrawal by Subject | 1 | 0 |
[1]
All participants were followed after treatment; thus, number started will not match number completed
[2]
Completed survival follow-up due to death
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Baseline Characteristics
Arm/Group Title | BV Extension | BV Retreatment | Total | |
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Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment) | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse) | Total of all reporting groups | |
Overall Number of Baseline Participants | 78 | 32 | 110 | |
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All participants who received treatment
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Age, Customized
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 78 participants | 32 participants | 110 participants | |
32
(15 to 78)
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37
(16 to 72)
|
33.5
(15 to 78)
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Gender
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 78 participants | 32 participants | 110 participants | |
Female |
35 44.9%
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17 53.1%
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52 47.3%
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Male |
43 55.1%
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15 46.9%
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58 52.7%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 78 participants | 32 participants | 110 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
3 3.8%
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0 0.0%
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3 2.7%
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Native Hawaiian or Other Pacific Islander |
1 1.3%
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0 0.0%
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1 0.9%
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Black or African American |
7 9.0%
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4 12.5%
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11 10.0%
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White |
66 84.6%
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27 84.4%
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93 84.5%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
1 1.3%
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1 3.1%
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2 1.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 78 participants | 32 participants | 110 participants |
France | 0 | 3 | 3 | |
United States | 78 | 29 | 107 | |
Eastern Cooperative Oncology Group Performance Status
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 78 participants | 32 participants | 110 participants |
0 | 47 | 12 | 59 | |
1 | 30 | 18 | 48 | |
2 | 0 | 2 | 2 | |
3-5 | 0 | 0 | 0 | |
Missing | 1 | 0 | 1 | |
[1]
Measure Description:
0 = Normal activity
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Disease diagnosis
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 78 participants | 32 participants | 110 participants |
Hodgkin lymphoma (HL) | 68 | 21 | 89 | |
Systemic anaplastic large cell lymphoma (ALCL) | 8 | 8 | 16 | |
Other | 2 | 3 | 5 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: | Chief Medical Officer |
Organization: | Seattle Genetics, Inc. |
Phone: | 855-473-2436 |
EMail: | medinfo@seagen.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Seagen Inc. |
ClinicalTrials.gov Identifier: | NCT00947856 |
Other Study ID Numbers: |
SGN35-006 2010-019932-11 ( EudraCT Number ) |
First Submitted: | July 24, 2009 |
First Posted: | July 28, 2009 |
Results First Submitted: | March 21, 2014 |
Results First Posted: | May 26, 2014 |
Last Update Posted: | February 2, 2017 |