Back to resultsStudy of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Primary Purpose
Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
brentuximab vedotin
brentuximab vedotin
rituximab
vincristine
cyclophosphamide
prednisone
doxorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, B-cell focused on measuring Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse, Monomethyl auristatin E
Eligibility Criteria
Inclusion Criteria:
- Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
- International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age
- Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL
Exclusion Criteria:
- Previous history of treated indolent lymphoma
- History of another primary malignancy that has not been in remission for 3 years
Sites / Locations
- Arizona Oncology Associates, PC - HAL
- Arizona Oncology Associates, PC - HOPE
- University of Arkansas for Medical Sciences
- Comprehensive Blood and Cancer Center
- City of Hope National Medical Center
- Sansum Clinic
- Stanford Cancer Center
- Rocky Mountain Cancer Centers - Aurora
- Augusta University
- Cardinal Bernardin Cancer Center / Loyola University Medical Center
- Illinois Cancer Specialists / Advocate Lutheran General Hospital
- Norton Cancer Institute
- Johns Hopkins Medical Center
- Henry Ford Health System
- Washington University School of Medicine
- Billings Clinic Cancer Research
- Comprehensive Cancer Centers of Nevada
- Summit Medical Group
- Jersey Shore University Medical Center
- New York Oncology Hematology, P.C.
- Mid Ohio Oncology/Hematology Inc
- Willamette Valley Cancer Institute and Research Center
- Northwest Cancer Specialists, P.C.
- Saint Francis Hospital / Bon Secours
- Tennessee Cancer Specialists
- Texas Oncology - Austin Midtown
- Texas Oncology - Baylor Sammons Cancer Center
- US Oncology Investigational Products Center (IPC)
- MD Anderson Cancer Center / University of Texas
- Texas Oncology - San Antonio Medical Center
- US Oncology Central Regulatory
- Texas Oncology - Tyler
- University of Utah
- Virginia Cancer Specialists, PC
- Virginia Commonwealth University Medical Center
- Benaroya Research Institute/Virginia Mason Medical Center
- Fakultni nemocnice Brno
- Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
- Fakultni Nemocnice Kralovske Vinohrady
- Fakultni nemocnice v Motole
- Centro di Riferimento Oncologico di Aviano
- Instituto di Ematologia ed Oncologia Medica
- Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara
- IRCCS Ospedale Casa Sollievo della Sofferenza
- COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
- Malopolskie Centrum Medyczne S.C.
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
- Hospital de la Santa Creu i Sant Paul
- Hospital Universitario Vall d'Hebron
- Institut Català D'oncologia
- Complejo Hospitalano de Navarra Servicio Hematologia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Experimental
Arm Label
Part 1: BV(1.2 mg/kg) + RCHOP
Part 1: BV(1.8 mg/kg) + RCHOP
Part 2: BV(1.8 mg/kg) + RCHP
Part 3: RCHOP
Part 3: BV(1.8 mg/kg) + RCHP
Arm Description
Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.2 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.8 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone Part 2 of the study is a phase 2, non-randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). Patients in this treatment arm were enrolled into a dosing cohort with 1.8 mg/kg brentuximab vedotin administered in combination with RCHP.
Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone.
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone. Randomization in this part of the study is for the purpose of evaluating the safety of 1.8 mg/kg brentuximab vedotin in combination with RCHP versus standard RCHOP chemotherapy. Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive 1.8 mg/kg brentuximab vedotin administered in combination with RCHP.
Outcomes
Primary Outcome Measures
Complete Remission Rate
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Incidence of Adverse Events
Number (count) of participants that experienced at least 1 adverse event.
Incidence of Laboratory Abnormalities
Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Secondary Outcome Measures
Objective Response Rate
Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)
Progression-free Survival
Median progression-free survival (in months) and observed minimum-maximum range.
Overall Survival
Median overall survival (in months) and observed minimum-maximum range.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01925612
Brief Title
Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Official Title
A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) as Front-line Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization and changing treatment landscape in frontline DLBCL
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups.
The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.
The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.
Detailed Description
In the first part of this study, patients in the 2 groups were tested to see if there was a difference in the response to treatment and whether there were differences in the side effects (unwanted effects).
The second and third parts of the study are being done to see if there are any side effects (unwanted effects) of the higher dose of brentuximab vedotin when combined with a modified version of RCHOP that omits vincristine. The third part of the study is being done to see if there is a difference between BV+RCHP and RCHOP in the response to treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse
Keywords
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse, Monomethyl auristatin E
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: BV(1.2 mg/kg) + RCHOP
Arm Type
Experimental
Arm Description
Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.2 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.
Arm Title
Part 1: BV(1.8 mg/kg) + RCHOP
Arm Type
Experimental
Arm Description
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.8 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.
Arm Title
Part 2: BV(1.8 mg/kg) + RCHP
Arm Type
Experimental
Arm Description
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
Part 2 of the study is a phase 2, non-randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). Patients in this treatment arm were enrolled into a dosing cohort with 1.8 mg/kg brentuximab vedotin administered in combination with RCHP.
Arm Title
Part 3: RCHOP
Arm Type
Active Comparator
Arm Description
Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone.
Arm Title
Part 3: BV(1.8 mg/kg) + RCHP
Arm Type
Experimental
Arm Description
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone. Randomization in this part of the study is for the purpose of evaluating the safety of 1.8 mg/kg brentuximab vedotin in combination with RCHP versus standard RCHOP chemotherapy.
Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive 1.8 mg/kg brentuximab vedotin administered in combination with RCHP.
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
Adcetris, SGN-35
Intervention Description
1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
Adcetris, SGN-35
Intervention Description
1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
vincristine
Intervention Description
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Intervention Description
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Primary Outcome Measure Information:
Title
Complete Remission Rate
Description
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Time Frame
Up to 6 months
Title
Incidence of Adverse Events
Description
Number (count) of participants that experienced at least 1 adverse event.
Time Frame
Up to 6 months
Title
Incidence of Laboratory Abnormalities
Description
Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)
Time Frame
Up to 6 months
Title
Progression-free Survival
Description
Median progression-free survival (in months) and observed minimum-maximum range.
Time Frame
Up to approximately 4 years
Title
Overall Survival
Description
Median overall survival (in months) and observed minimum-maximum range.
Time Frame
Up to approximately 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age
Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease
Measurable disease of at least 1.5 cm
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL
Exclusion Criteria:
Previous history of treated indolent lymphoma
History of another primary malignancy that has not been in remission for 3 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Ruffner
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC - HAL
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Cardinal Bernardin Cancer Center / Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
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
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Billings Clinic Cancer Research
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
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
Summit Medical Group
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Mid Ohio Oncology/Hematology Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Northwest Cancer Specialists, P.C.
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Saint Francis Hospital / Bon Secours
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology - Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
US Oncology Investigational Products Center (IPC)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States
Facility Name
Texas Oncology - San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
US Oncology Central Regulatory
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
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
Benaroya Research Institute/Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni Nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Centro di Riferimento Oncologico di Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Instituto di Ematologia ed Oncologia Medica
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Malopolskie Centrum Medyczne S.C.
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Hospital de la Santa Creu i Sant Paul
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Català D'oncologia
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Complejo Hospitalano de Navarra Servicio Hematologia
City
Pamplona
ZIP/Postal Code
31130
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
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