Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
NCT ID: NCT01925612
Last Updated: 2018-06-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
87 participants
INTERVENTIONAL
2013-08-31
2017-05-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: BV(1.2 mg/kg) + RCHOP
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
1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Part 1: BV(1.8 mg/kg) + 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 by IV infusion every 3 weeks for up to 6 cycles
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Part 2: BV(1.8 mg/kg) + RCHP
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.
brentuximab vedotin
1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Part 3: RCHOP
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.
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Part 3: BV(1.8 mg/kg) + RCHP
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.
brentuximab vedotin
1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Interventions
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brentuximab vedotin
1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
brentuximab vedotin
1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of another primary malignancy that has not been in remission for 3 years
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Katherine Ruffner
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
City of Hope National Medical Center
Duarte, California, United States
Sansum Clinic
Santa Barbara, California, United States
Stanford Cancer Center
Stanford, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Augusta University
Augusta, Georgia, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Billings Clinic Cancer Research
Billings, Montana, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Summit Medical Group
Morristown, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Mid Ohio Oncology/Hematology Inc
Columbus, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States
Saint Francis Hospital / Bon Secours
Greenville, South Carolina, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Texas Oncology - Austin Midtown
Austin, Texas, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States
US Oncology Investigational Products Center (IPC)
Fort Worth, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
US Oncology Central Regulatory
The Woodlands, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Benaroya Research Institute/Virginia Mason Medical Center
Seattle, Washington, United States
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
Hradec Králové, , Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Centro di Riferimento Oncologico di Aviano
Aviano, , Italy
Instituto di Ematologia ed Oncologia Medica
Bologna, , Italy
Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara
Pisa, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, , Poland
Malopolskie Centrum Medyczne S.C.
Krakow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
Olsztyn, , Poland
Hospital de la Santa Creu i Sant Paul
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Institut Català D'oncologia
L'Hospitalet de Llobregat, , Spain
Complejo Hospitalano de Navarra Servicio Hematologia
Pamplona, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGN35-017
Identifier Type: -
Identifier Source: org_study_id
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