Non Hodgkin Lymphoma Clinical Trial

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

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.

View Full Description

Full 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).

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT01716806

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 53 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35249, United States More Info
Amitkumar Mehta
Contact
[email protected]
Amitkumar Mehta
Principal Investigator
University of South Alabama - Mitchell Cancer Institute
Mobile Alabama, 36604, United States More Info
Omar Alkharabsheh
Principal Investigator
Alaska Urological Institute
Anchorage Alaska, 99503, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Jana Bergelin
Contact
480-256-5168
[email protected]
Horst Klueppelberg
Principal Investigator
Arizona Oncology Associates, PC - HOPE
Tucson Arizona, 85710, United States More Info
Donald Brooks
Principal Investigator
Arizona Cancer Center / University of Arizona
Tucson Arizona, 85724, United States
Highlands Oncology Group
Springdale Arkansas, J. Th, United States More Info
Mary Sullivan
Contact
479-695-4168
[email protected]
J. Thaddeus Beck
Principal Investigator
Providence St Joseph Medical Center
Burbank California, 91505, United States More Info
Karlton Wong
Principal Investigator
City of Hope National Medical Center
Duarte California, 91010, United States More Info
Matthew Mei
Principal Investigator
Wilshire Oncology Medical Group Inc.
Pomona California, 91767, United States
Rocky Mountain Cancer Centers - Aurora
Aurora Colorado, 80012, United States More Info
John Burke
Principal Investigator
Florida Cancer Affiliates
Trinity Florida, 34655, United States
IACT Health
Columbus Georgia, 31904, United States More Info
Grayson Scott
Contact
888-737-7408
[email protected]
Andrew Pippas
Principal Investigator
Georgia Cancer Specialists / Northside Hospital Cancer Institute
Sandy Springs Georgia, 30341, United States More Info
Rodolfo Bordoni
Principal Investigator
Rush University Medical Center
Chicago Illinois, 60612, United States
Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles Illinois, 60714, United States
American Oncology Networks LLC
Bethesda Maryland, 20817, United States More Info
Taylor Stutzman
Contact
301-571-2016
[email protected]
Ralph Boccia
Principal Investigator
Karmanos Cancer Institute / Wayne State University
Detroit Michigan, 48201, United States
Minnesota Oncology Hematology P.A.
Minneapolis Minnesota, 55404, United States More Info
Timothy Larson
Principal Investigator
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States More Info
Clark Jean
Principal Investigator
Morristown Medical Center/ Carol G. Simon Cancer Center
Morristown New Jersey, 07960, United States More Info
Charles Farber
Principal Investigator
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
New York Oncology Hematology, P.C.
Albany New York, 12208, United States
Columbia University Medical Center
New York New York, 10032, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester New York, 14642, United States More Info
Jonathan Friedberg
Principal Investigator
Oncology Hematology Care
Cincinnati Ohio, 45242, United States More Info
James Essell
Principal Investigator
James Cancer Hospital / Ohio State University
Columbus Ohio, 43210, United States
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States More Info
Christopher Yasenchak
Principal Investigator
Northwest Cancer Specialists, P.C.
Tigard Oregon, 97223, United States More Info
Spencer Shao
Principal Investigator
Prisma Health
Greenville South Carolina, 29615, United States More Info
Christopher Thomas
Principal Investigator
Arlington Cancer Center
Arlington Texas, 76012, United States More Info
Scott Fleischauer
Principal Investigator
Texas Oncology - Bedford
Bedford Texas, 76022, United States More Info
Henrik Illum
Principal Investigator
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas Texas, 75231, United States More Info
Nancy Jones
Contact
214-265-2080
[email protected]
Kristi McIntyre
Principal Investigator
Texas Oncology - Denton South
Denton Texas, Kurku, United States More Info
Charles Kurkul
Principal Investigator
Texas Oncology - Fort Worth 12th Avenue
Fort Worth Texas, 76104, United States More Info
Robert Ruxer
Principal Investigator
Houston Methodist Cancer Center
Houston Texas, 77030, United States
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Hun Ju Lee
Principal Investigator
Texas Oncology - Longview
Longview Texas, 75601, United States More Info
Lijo John
Principal Investigator
Texas Oncology - McAllen
McAllen Texas, 78503, United States More Info
Suresh Ratnam
Contact
956-687-5150
[email protected]
Suresh Ratnam
Principal Investigator
Texas Oncology - Seton Williamson
Round Rock Texas, 78665, United States More Info
Vivian Cline
Principal Investigator
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States More Info
Dipti Patel-Donnelly
Principal Investigator
Virginia Commonwealth University Medical Center
Richmond Virginia, 23298, United States More Info
Kristin Lantis
Contact
804-828-2177
[email protected]
Victor Yazbeck
Principal Investigator
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Salem Virginia, 24153, United States More Info
Jerome Goldschmidt
Principal Investigator
Shenandoah Oncology P.C.
Winchester Virginia, 22601, United States
Benaroya Research Institute/Virginia Mason Medical Center
Seattle Washington, 98101, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Wenatchee Valley Medical Center
Wenatchee Washington, 98821, United States
Carbone Cancer Center / University of Wisconsin
Madison Wisconsin, 53792, United States More Info
Mariah Endres
Contact
608-263-1836
[email protected]
Chris Fletcher
Principal Investigator
University of Alberta / Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
London Health Sciences Centre - Victoria Hospital
London Ontario, N6A 5, Canada More Info
Selay Lam
Principal Investigator
CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada More Info
Sylvie Lachance
Principal Investigator
Jewish General Hospital
Montreal Quebec, H3T 1, Canada More Info
Nathalie Johnson
Principal Investigator
Royal Victoria Hospital, McGill University Health Centre
Montreal Quebec, H4A 3, Canada More Info
Kelly Davison
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT01716806

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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