A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms
NCT ID: NCT01309789
Last Updated: 2017-06-28
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
39 participants
INTERVENTIONAL
2011-02-28
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Sequential
brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 3-8)
prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 3-8)
vincristine
1.4 mg/m2 IV every 3 weeks (Cycles 3-8)
2
Combination
brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 1-6)
doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 1-6)
prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
3 Brentuximab vedotin/CH-P
Combination
brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 1-6)
doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 1-6)
prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
Interventions
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brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 3-8)
brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 1-6)
doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 3-8)
doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 1-6)
prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
vincristine
1.4 mg/m2 IV every 3 weeks (Cycles 3-8)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease of at least 1.5 cm
* ECOG performance status less than or equal to 2
Exclusion Criteria
* Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
* History of another primary malignancy that has not been in remission for at least 3 years
* Left ventricular ejection fraction \<45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
* Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
* Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status
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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Dana Kennedy, PharmD, BCOP
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Stanford Cancer Center
Stanford, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
St. Francis Hospital
Greenville, South Carolina, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, United States
Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.
Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Uttarwar M, Lee SY, Ren H, Kennedy DA, Shustov AR. Five-year outcomes for frontline brentuximab vedotin with CHP for CD30-expressing peripheral T-cell lymphomas. Blood. 2018 May 10;131(19):2120-2124. doi: 10.1182/blood-2017-12-821009. Epub 2018 Mar 5.
Other Identifiers
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2010-022839-11
Identifier Type: -
Identifier Source: secondary_id
SGN35-011
Identifier Type: -
Identifier Source: org_study_id
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