Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-cell Lymphoma
NCT ID: NCT02594163
Last Updated: 2018-10-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2015-10-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brentuximab Vedotin
Subjects randomized to the brentuximab vedotin arm will receive IV infusions of brentuximab vedotin followed by bendamustine on day 1, and rituximab followed by bendamustine on day 2 of each 21 day cycle.
Brentuximab Vedotin
Rituximab
Bendamustine
Rituximab,Bendamustine control
Subjects randomized to the control arm will receive IV infusions of rituximab on day 1 or day 2 and bendamustine on both days 1 and 2 of each 21 day cycle.
Rituximab
Bendamustine
Interventions
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Brentuximab Vedotin
Rituximab
Bendamustine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must have relapsed or refractory disease following:
1. second-line or greater salvage systemic therapy, or
2. frontline cytotoxic systemic therapy, for patients who are ineligible for stem cell transplant (SCT).
3. Age 18 years and older.
4. Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET).
5. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
6. Acceptable blood test results.
7. Females of childbearing potential must have a negative pregnancy test result within 7 days prior to the first dose of study drug.
8. Females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of brentuximab vedotin or 12 months following the last dose of rituximab, whichever is later.
9. Patients must provide written informed consent.
Exclusion Criteria
2. History of progressive multifocal leukoencephalopathy (PML).
3. Cerebral/meningeal disease related to the underlying malignancy, unless definitively treated.
4. Viral, bacterial, or fungal infection within 2 weeks prior to the first dose of treatment.
5. Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug.
6. Females who are pregnant or breastfeeding.
7. Known allergy to any study drug or ingredient contained in the drug formulation of any of the study drugs.
8. Known to be positive for hepatitis B. Known to have active hepatitis C infection or on antiviral therapy for hepatitis C within the last 6 months.
9. Known to be positive for human immunodeficiency virus (HIV).
10. Patients with previous allogeneic stem cell transplant.
11. Previous treatment with brentuximab vedotin or bendamustine.
12. Intolerable toxicity to prior rituximab therapy.
13. Current therapy with other investigational agents.
14. Lung disease unrelated to underlying malignancy.
15. History of a stroke or transient ischemic attack, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to the first dose of treatment.
16. Congestive heart failure.
17. Significant peripheral sensory or motor neuropathy at the start of the study.
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Manley, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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City of Hope
Duarte, California, United States
Sansum Clinic - West Pueblo
Santa Barbara, California, United States
Good Samaritan Hospital
Torrance, California, United States
The Oncology Institute of Hope and Innovation
Whittier, California, United States
Rocky Mountain Cancer Center
Aurora, Colorado, United States
Kaiser Permanente Oncology
Lonetree, Colorado, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
Saint Francis Cancer Treatment Center
Grand Island, Nebraska, United States
Hematology and Oncology Associates of Northern New Jersey, P.A.
Morristown, New Jersey, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States
Bon Secours Saint Francis Hospital
Greenville, South Carolina, United States
Greenville Health System Institutional Review Board
Greenville, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Oncology - Flower Mound
Denton, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
Virginia Mason Clinical Research
Seattle, Washington, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
FN Brno
Brno, , Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultní nemocnice Královské Vinohrady
Prague, , Czechia
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan
Brest, , France
CHU Côte de Nacre - Caen
Caen, , France
Centre Hospitalier des Oudairies
La Roche-sur-Yon, , France
Centre Hospitalier du Mans
Le Rocher, , France
CHR Metz
Metz, , France
Centre Hospitalier Universitaire de Nantes (CHU Nantes) - Hotel Dieu
Nantes, , France
Centre Hospitalier de Perpignan
Perpignan, , France
Centre Hospitalier Universitaire (CHU) de Poitier- Hopital de la Miletrie - Hopital Jean Bernard
Poitiers, , France
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes, , France
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
IRCSS Policlinico San Matteo
Pavia, , Italy
Azienda Policlinico Umberto I di Roma
Roma, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
A.O Ospadale Di Circolo E Fondazione Macchi
Varese, , Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Wojewódzki Szpital Specjalistyczny
Lodz, , Poland
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Puerta de Hierro
Majadahonda, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, , Spain
University Hospital's Birmingham NHS Foundation trust-Queen Elizabeth Hospital
Birmingham, , United Kingdom
Liverpool and Broadgreen Hospital
Liverpool, , United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, , United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
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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SGN35-023
Identifier Type: -
Identifier Source: org_study_id
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