A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
NCT ID: NCT01716806
Last Updated: 2024-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2012-10-31
2023-09-12
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
PARALLEL
TREATMENT
NONE
Study Groups
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Part A: Brentuximab Vedotin in HL Patients
brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
dacarbazine
375 mg/m\^2 every 3 weeks by IV infusion
Part C: Brentuximab Vedotin + Bendamustine in HL Patients
brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
bendamustine
70 mg/m\^2 by IV infusion on Days 1 and 2 of 3-week cycle
Part D: Brentuximab Vedotin + Nivolumab in HL Patients
brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
nivolumab
3 mg/kg every 3 weeks by IV infusion
Part E: Brentuximab Vedotin in HL Patients
brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Part F: Brentuximab Vedotin in PTCL Patients
brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Interventions
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brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
bendamustine
70 mg/m\^2 by IV infusion on Days 1 and 2 of 3-week cycle
dacarbazine
375 mg/m\^2 every 3 weeks by IV infusion
nivolumab
3 mg/kg every 3 weeks by IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
* Treatment-naive patients with CD30-expressing PTCL (Part F)
* Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
* Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
* A CIRS score of 10 or greater
* Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
* Measurable disease of at least 1.5 cm as documented by radiographic technique
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
Exclusion Criteria
* History of progressive multifocal leukoencephalopathy
* Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
* Concurrent use of other investigational agents
* Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
* History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
* Part D only:
* Received any prior immune-oncology therapy
* History of known or suspected autoimmune disease
* Prior allogeneic stem cell transplant
* History of cerebral vascular event within 6 months of first dose of study drug
* Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
* Known history of pancreatitis
* Parts D, E, and F only:
* Known cerebral/meningeal disease related to the underlying malignancy
* Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Sims, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama - Mitchell Cancer Institute
Mobile, Alabama, United States
Alaska Urological Institute
Anchorage, Alaska, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Arizona Cancer Center / University of Arizona
Tucson, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Providence St Joseph Medical Center
Burbank, California, United States
City of Hope National Medical Center
Duarte, California, United States
Wilshire Oncology Medical Group Inc.
Pomona, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Florida Cancer Affiliates
Trinity, Florida, United States
IACT Health
Columbus, Georgia, United States
Georgia Cancer Specialists / Northside Hospital Cancer Institute
Sandy Springs, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles, Illinois, United States
American Oncology Networks LLC
Bethesda, Maryland, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States
Minnesota Oncology Hematology P.A.
Minneapolis, Minnesota, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Morristown Medical Center/ Carol G. Simon Cancer Center
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Columbia University Medical Center
New York, New York, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester, New York, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
James Cancer Hospital / Ohio State University
Columbus, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, United States
Prisma Health
Greenville, South Carolina, United States
Arlington Cancer Center
Arlington, Texas, United States
Texas Oncology - Bedford
Bedford, Texas, United States
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas, Texas, United States
Texas Oncology - Denton South
Denton, Texas, United States
Texas Oncology - Fort Worth 12th Avenue
Fort Worth, Texas, United States
Houston Methodist Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Texas Oncology - Longview
Longview, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology - Seton Williamson
Round Rock, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Salem, Virginia, United States
Shenandoah Oncology P.C.
Winchester, Virginia, United States
Benaroya Research Institute/Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States
University of Alberta / Cross Cancer Institute
Edmonton, Alberta, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Royal Victoria Hospital, McGill University Health Centre
Montreal, Quebec, Canada
Countries
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References
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Friedberg JW, Bordoni R, Patel-Donnelly D, Larson T, Goldschmidt J, Boccia R, Cline VJM, Mamidipalli A, Liu J, Akyol A, Yasenchak CA. Brentuximab vedotin with dacarbazine or nivolumab as frontline cHL therapy for older patients ineligible for chemotherapy. Blood. 2024 Feb 29;143(9):786-795. doi: 10.1182/blood.2022019536.
Friedberg JW, Forero-Torres A, Bordoni RE, Cline VJM, Patel Donnelly D, Flynn PJ, Olsen G, Chen R, Fong A, Wang Y, Yasenchak CA. Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged >/=60 years with HL. Blood. 2017 Dec 28;130(26):2829-2837. doi: 10.1182/blood-2017-06-787200. Epub 2017 Oct 16.
Forero-Torres A, Holkova B, Goldschmidt J, Chen R, Olsen G, Boccia RV, Bordoni RE, Friedberg JW, Sharman JP, Palanca-Wessels MC, Wang Y, Yasenchak CA. Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older. Blood. 2015 Dec 24;126(26):2798-804. doi: 10.1182/blood-2015-06-644336. Epub 2015 Sep 16.
Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. doi: 10.3109/10428194.2013.876496. Epub 2014 Feb 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGN35-015
Identifier Type: -
Identifier Source: org_study_id
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