Back to resultsA Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
Primary Purpose
Hodgkin Disease, Peripheral T Cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
brentuximab vedotin
bendamustine
dacarbazine
nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Disease focused on measuring Antibody-Drug Conjugate, Antibodies, Monoclonal, Hematologic Diseases, Hodgkin Disease, Antigens, CD30, Lymphoma, monomethylauristatin E, Drug Therapy, CD30-expression, PTCL, Seattle Genetics
Eligibility Criteria
Inclusion Criteria:
- Parts A, B, C, and D: 60 years of age or older
- 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:
- Symptomatic neurologic disease compromising IADLs or requiring medication
- 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
Sites / Locations
- University of Alabama at Birmingham
- University of South Alabama - Mitchell Cancer Institute
- Alaska Urological Institute
- Banner MD Anderson Cancer Center
- Arizona Oncology Associates, PC - HOPE
- Arizona Cancer Center / University of Arizona
- Highlands Oncology Group
- Providence St Joseph Medical Center
- City of Hope National Medical Center
- Wilshire Oncology Medical Group Inc.
- Rocky Mountain Cancer Centers - Aurora
- Florida Cancer Affiliates
- IACT Health
- Georgia Cancer Specialists / Northside Hospital Cancer Institute
- Rush University Medical Center
- Illinois Cancer Specialists / Advocate Lutheran General Hospital
- American Oncology Networks LLC
- Karmanos Cancer Institute / Wayne State University
- Minnesota Oncology Hematology P.A.
- Nebraska Cancer Specialists
- Comprehensive Cancer Centers of Nevada
- Morristown Medical Center/ Carol G. Simon Cancer Center
- Rutgers Cancer Institute of New Jersey
- New York Oncology Hematology, P.C.
- Columbia University Medical Center
- James P. Wilmot Cancer Center / University of Rochester Medical Center
- Oncology Hematology Care
- James Cancer Hospital / Ohio State University
- Willamette Valley Cancer Institute and Research Center
- Northwest Cancer Specialists, P.C.
- Prisma Health
- Arlington Cancer Center
- Texas Oncology - Bedford
- Texas Oncology - Presbyterian Cancer Center Dallas
- Texas Oncology - Denton South
- Texas Oncology - Fort Worth 12th Avenue
- Houston Methodist Cancer Center
- MD Anderson Cancer Center / University of Texas
- Texas Oncology - Longview
- Texas Oncology - McAllen
- Texas Oncology - Seton Williamson
- Virginia Cancer Specialists, PC
- Virginia Commonwealth University Medical Center
- Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
- Shenandoah Oncology P.C.
- Benaroya Research Institute/Virginia Mason Medical Center
- Swedish Cancer Institute
- Wenatchee Valley Medical Center
- Carbone Cancer Center / University of Wisconsin
- University of Alberta / Cross Cancer Institute
- London Health Sciences Centre - Victoria Hospital
- CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont
- Jewish General Hospital
- Royal Victoria Hospital, McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part A: Brentuximab Vedotin in HL Patients
Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
Part C: Brentuximab Vedotin + Bendamustine in HL Patients
Part D: Brentuximab Vedotin + Nivolumab in HL Patients
Part E: Brentuximab Vedotin in HL Patients
Part F: Brentuximab Vedotin in PTCL Patients
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate (ORR) according to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
Defined as the proportion of patients with complete response (CR) or (PR)
ORR according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
ORR according to modified Lugano criteria per blinded independent central review (BICR) (Parts E and F)
Secondary Outcome Measures
Incidence of adverse events
Incidence of laboratory abnormalities
Complete remission (CR) rate
Defined as the proportion of patients with CR
Duration of complete response
Defined as the time from start of the first documentation of complete tumor response (CR) to the first documentation of tumor progression or death
Duration of objective response
Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or death
Progression-free survival
Defined as the time from start of study treatment to first documentation of tumor progression or death due to any cause
Disease control rate
Defined as the proportion of patients with CR, PR, or stable disease (SD)
ORR according to Lugano criteria per BICR (Parts E and F)
B symptom resolution rate
Defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period
Blood concentrations of brentuximab vedotin
Incidence of brentuximab vedotin antitherapeutic antibodies (ATA)
Defined as the proportion of patients who develop ATA to brentuximab vedotin at any time during the study
Blood concentrations of nivolumab (Part D only)
Incidence of nivolumab antitherapeutic antibodies (ATA) (Part D only)
Defined as the proportion of patients who develop ATA to nivolumab at any time during the study
Overall survival (Parts E and F only)
Defined as the time from start of study treatment to date of death due to any cause
Full Information
NCT ID
NCT01716806
First Posted
October 16, 2012
Last Updated
September 26, 2023
Sponsor
Seagen Inc.
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01716806
Brief Title
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
Official Title
A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 31, 2012 (Actual)
Primary Completion Date
April 7, 2023 (Actual)
Study Completion Date
September 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
Detailed Description
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease, Peripheral T Cell Lymphoma
Keywords
Antibody-Drug Conjugate, Antibodies, Monoclonal, Hematologic Diseases, Hodgkin Disease, Antigens, CD30, Lymphoma, monomethylauristatin E, Drug Therapy, CD30-expression, PTCL, Seattle Genetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: Brentuximab Vedotin in HL Patients
Arm Type
Experimental
Arm Title
Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
Arm Type
Experimental
Arm Title
Part C: Brentuximab Vedotin + Bendamustine in HL Patients
Arm Type
Experimental
Arm Title
Part D: Brentuximab Vedotin + Nivolumab in HL Patients
Arm Type
Experimental
Arm Title
Part E: Brentuximab Vedotin in HL Patients
Arm Type
Experimental
Arm Title
Part F: Brentuximab Vedotin in PTCL Patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
Adcetris; SGN-35
Intervention Description
1.8 mg/kg every 3 weeks by IV infusion
Intervention Type
Drug
Intervention Name(s)
bendamustine
Intervention Description
70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle
Intervention Type
Drug
Intervention Name(s)
dacarbazine
Intervention Description
375 mg/m^2 every 3 weeks by IV infusion
Intervention Type
Drug
Intervention Name(s)
nivolumab
Intervention Description
3 mg/kg every 3 weeks by IV infusion
Primary Outcome Measure Information:
Title
Objective response rate (ORR) according to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
Description
Defined as the proportion of patients with complete response (CR) or (PR)
Time Frame
Through 1 month following last dose; up to approximately 16 months
Title
ORR according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
Time Frame
Through 1 month following last dose; up to approximately 16 months
Title
ORR according to modified Lugano criteria per blinded independent central review (BICR) (Parts E and F)
Time Frame
Through 1 month following last dose; up to approximately 16 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
Title
Incidence of laboratory abnormalities
Time Frame
Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
Title
Complete remission (CR) rate
Description
Defined as the proportion of patients with CR
Time Frame
Through 1 month following last dose; up to approximately 16 months
Title
Duration of complete response
Description
Defined as the time from start of the first documentation of complete tumor response (CR) to the first documentation of tumor progression or death
Time Frame
Up to approximately 10 years
Title
Duration of objective response
Description
Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or death
Time Frame
Up to approximately 10 years
Title
Progression-free survival
Description
Defined as the time from start of study treatment to first documentation of tumor progression or death due to any cause
Time Frame
Up to approximately 10 years
Title
Disease control rate
Description
Defined as the proportion of patients with CR, PR, or stable disease (SD)
Time Frame
Up to approximately 10 years
Title
ORR according to Lugano criteria per BICR (Parts E and F)
Time Frame
Through 1 month following last dose; up to approximately 16 months
Title
B symptom resolution rate
Description
Defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period
Time Frame
Through 1 month following last dose; up to approximately 16 months
Title
Blood concentrations of brentuximab vedotin
Time Frame
Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes
Title
Incidence of brentuximab vedotin antitherapeutic antibodies (ATA)
Description
Defined as the proportion of patients who develop ATA to brentuximab vedotin at any time during the study
Time Frame
Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose
Title
Blood concentrations of nivolumab (Part D only)
Time Frame
Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes
Title
Incidence of nivolumab antitherapeutic antibodies (ATA) (Part D only)
Description
Defined as the proportion of patients who develop ATA to nivolumab at any time during the study
Time Frame
Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose
Title
Overall survival (Parts E and F only)
Description
Defined as the time from start of study treatment to date of death due to any cause
Time Frame
Up to approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parts A, B, C, and D: 60 years of age or older
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:
Symptomatic neurologic disease compromising IADLs or requiring medication
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Sims, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
University of South Alabama - Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Alaska Urological Institute
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Arizona Cancer Center / University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
J. Thaddeus Beck
Country
United States
Facility Name
Providence St Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Wilshire Oncology Medical Group Inc.
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Florida Cancer Affiliates
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
IACT Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Georgia Cancer Specialists / Northside Hospital Cancer Institute
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Cancer Specialists / Advocate Lutheran General Hospital
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
American Oncology Networks LLC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Karmanos Cancer Institute / Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Minnesota Oncology Hematology P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Morristown Medical Center/ Carol G. Simon Cancer Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center / University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
James Cancer Hospital / Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Northwest Cancer Specialists, P.C.
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology - Presbyterian Cancer Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology - Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
Kurkul
Country
United States
Facility Name
Texas Oncology - Fort Worth 12th Avenue
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Houston Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - Longview
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Texas Oncology - McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Texas Oncology - Seton Williamson
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78665
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Shenandoah Oncology P.C.
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Benaroya Research Institute/Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98821
Country
United States
Facility Name
Carbone Cancer Center / University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
University of Alberta / Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
London Health Sciences Centre - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Royal Victoria Hospital, McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
29038340
Citation
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.
Results Reference
derived
PubMed Identifier
26377597
Citation
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.
Results Reference
derived
PubMed Identifier
24359243
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
We'll reach out to this number within 24 hrs