Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2010-01-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
brentuximab vedotin
brentuximab vedotin
1.8 mg/kg IV every 21 days
Interventions
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brentuximab vedotin
1.8 mg/kg IV every 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate organ function
* ECOG performance status \<2
Exclusion Criteria
* Current diagnosis of primary cutaneous ALCL
* Acute or chronic graft-versus-host disease
* Prior hematopoietic stem cell transplant within specified timeframe
18 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Naomi Hunder, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Stanford Cancer Center
Stanford, California, United States
University of Miami Hospital and Clinics, Miller School of Medicine
Miami, Florida, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
New York University Cancer Institute
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
University Hospital of Cologne
Cologne, , Germany
Countries
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References
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Han TH, Chen R, Advani R, Berryman RB, Smith SE, Forero-Torres A, Rosenblatt JD, Smith MR, Zain J, Hunder NN, Engert A. Brentuximab vedotin does not cause clinically relevant QTc interval prolongation in patients with CD30-positive hematologic malignancies. Cancer Chemother Pharmacol. 2013 Jul;72(1):241-9. doi: 10.1007/s00280-013-2192-z. Epub 2013 May 30.
Rothe A, Sasse S, Goergen H, Eichenauer DA, Lohri A, Jager U, Bangard C, Boll B, von Bergwelt Baildon M, Theurich S, Borchmann P, Engert A. Brentuximab vedotin for relapsed or refractory CD30+ hematologic malignancies: the German Hodgkin Study Group experience. Blood. 2012 Aug 16;120(7):1470-2. doi: 10.1182/blood-2012-05-430918. Epub 2012 Jul 11.
Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.
Other Identifiers
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SGN35-007
Identifier Type: -
Identifier Source: org_study_id